NCT06787586Befejeződött1. fázis
Safety, Tolerability and PK of ATTO-1310 in Healthy Volunteers and Patients With Atopic Dermatitis and Patients With Chronic Pruritus
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single Ascending Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and PK of ATTO1310 in Adult Volunteers, Patients With Atopic Dermatitis, and Patients With Chronic Pruritus
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 11.
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of ATTO-1310 in healthy adults, patients with atopic dermatitis and patients with chronic pruritus. The main questions it aims to answer are: What medical problems do participants have when taking ATTO-1310? How long does ATTO-1310 stay in the body after dosing? Researchers will compare ATTO-1310 to a placebo (a look-alike substance that contains no drug). Participants will be dosed with ATTO-1310 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 108 (tényleges)
- Első benyújtás
- 2024. dec. 26.
- Kezdés
- 2025. jan. 14.
- Elsődleges befejezés
- 2026. jún. 11.
- Fő szponzor
- Attovia Therapeutics Inc
- Betegségek
- Atópiás dermatitisz (ekcéma)
- NCT-szám
- NCT06787586
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Bevont résztvevők: 108
- 2025. jan. 14. és az elsődleges befejezés (2026. jún. 11.) között
- 17 helyszín, 2 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- History of major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study
- Subject has applied topical corticosteroid in the 14 days preceding Day 1
- Subject has used prohibited medications or therapies during the specified washout period before Day 1 (as defined in the protocol)
- Suspected diagnosis of drug-induced pruritus
- Major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study
- Use of prohibited medications as defined in the Protocol
Más betegség
- Any clinically significant underlying illness
- History of a clearly defined etiology for pruritus other than AD, including but not limited to urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection
- History of malignancy within 5 years of Screening
- History of asthma requiring regular use of a bronchodilator or a daily maintenance therapy
- History of recurrent eczema herpeticum
- History of known primary immunodeficiency, is considered immunocompromised, history of untreated latent tuberculosis infection, has been treated for active tuberculosis in the past year, or has been treated for a parasitic infection in the past 6 months
- History of major depression
- History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients (sucrose, polysorbate 80, or histidine)
- Active HBV or HCV or is positive for HIV
- History of drug or alcohol abuse
- Regional neuropathic disease associated with pruritus
- Severe renal failure requiring dialysis
- Untreated cholestatic liver disease
- History of infectious dermatoses
- History of malignancy within 5 years of Screening
- History of unexplained fevers, night sweats, or unintentional weight loss
- History of asthma requiring regular use of a bronchodilator or a daily maintenance therapy
- History of known primary immunodeficiency, is considered immunocompromised, untreated latent tuberculosis infection, has been treated for active tuberculosis in the past year, or has been treated for a parasitic infection in the past 6 months
- History of attempted suicide
- History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients (sucrose, polysorbate 80, or histidine)
- Active HBV or HCV or is positive for HIV.
- History of drug or alcohol abuse
Laborértékek
- Laboratory values outside of the normal range
- Liver function tests (bilirubin, AST, ALT, alkaline phosphatase) >2.5 times above the upper limit of normal
Egyéb
- Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day
- ECG with a QTcF > 450 msec for males or > 470 msec for females at Screening
- Primary dermatologic diagnosis associated with pruritic skin lesions at the time of screening
- Suspected diagnosis of somatoform pruritus
- Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day
- ECG with a QTcF > 450 msec for males or > 470 msec for females at Screening
A regiszterben nem jelölt feltételek
- Parts 1 \& 2 (Healthy Volunteers) Key Inclusion Criteria:
- Any sex or gender who is 18 to 65 years old
- Body weight of 50 to 125 kg and body mass index (BMI) between 18.5 and 35 kg/m2
- Considered in good general health based on medical history, physical exam, 12-lead ECG, screening clinical laboratory findings, and vital signs
- Negative pregnancy test for subjects of child-bearing potential
- Use of highly effective forms of birth control
- Part 3 (Subjects with Atopic Dermatitis) Inclusion Criteria:
- Any sex or gender who is 18 to 65 years old
- Body weight of 50 to 125 kg and BMI between 18.5 and 40 kg/m2
- Clinically confirmed diagnosis of active AD
- At least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before Screening
- Baseline weekly mean of daily PP-NRS ≥ 7 at Day 1
- EASI score of ≥ 7 at Screening and Day 1
- vIGA-AD score of ≥ 3 at Screening and Day 1
- Use of topical bland emollient (moisturizer) once or twice daily for at least 5 of the 7 days immediately before Day 1 and agrees to continue using that same emollient at the same frequency throughout the study
- Negative pregnancy test for subjects of child-bearing potential
- Use of highly effective forms of birth control
- Part 4 (Subjects with Chronic Pruritus) Inclusion Criteria:
- Any sex or gender who is 18 to 85 years old
- Body weight of 50 to 125 kg, inclusive, and BMI between 18.5 and 40 kg/m2
- Has had chronic pruritus for at least 6 months and is unresponsive to at least a 2-week course of emollient use.
- Chronic pruritus that affects at least 2 of the following body areas: legs, arms, or trunk
- A single PP-NRS score of ≥ 5 in the 24-hour period prior to the Screening visit
- Baseline weekly mean of daily PP-NRS ≥ 7 at Day 1
- Use of a stable dose of topical bland emollient (moisturizer) once or twice daily for at least 2 weeks before Day 1 and agrees to continue using that same emollient at the same frequency throughout the study
- Negative pregnancy test for subjects of child-bearing potential
- Use of highly effective forms of birth control
- Parts 1 \& 2 (Healthy Volunteers) Exclusion Criteria:
- Any clinically significant underlying illness.
- History of malignancy within 5 years of Screening, except adequately treated basal carcinoma or in situ carcinoma of the cervix.
- History of major surgery within 8 weeks prior to Day 1
- History of asthma requiring regular use of a bronchodilator or a daily maintenance therapy
- History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients (sucrose, polysorbate 80, or histidine)
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or is positive for HIV
- Active or latent tuberculosis infection
- Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day
- History of drug or alcohol abuse
- Laboratory values outside of the normal range
Életkor a regiszterben: 18 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (17)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| - | Fredericton | Kanada | Ismeretlen állapot |
| Altasciences | Montreal | Kanada | Ismeretlen állapot |
| - | Montreal | Kanada | Ismeretlen állapot |
| - | Newmarket | Kanada | Ismeretlen állapot |
| - | Peterborough | Kanada | Ismeretlen állapot |
| - | Toronto | Kanada | Ismeretlen állapot |
| - | Coral Gables | Egyesült Államok | Ismeretlen állapot |
| - | Encinitas | Egyesült Államok | Ismeretlen állapot |
| - | Margate | Egyesült Államok | Ismeretlen állapot |
| - | New York | Egyesült Államok | Ismeretlen állapot |
| - | New York | Egyesült Államok | Ismeretlen állapot |
| - | Plainfield | Egyesült Államok | Ismeretlen állapot |
| - | Reno | Egyesült Államok | Ismeretlen állapot |
| - | Rocklin | Egyesült Államok | Ismeretlen állapot |
| - | Sacramento | Egyesült Államok | Ismeretlen állapot |
| - | Saint Joseph | Egyesült Államok | Ismeretlen állapot |
| - | San Antonio | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.