NCT05984992CompletedPhase 1
The First-in-human Study of SRN-001 in Healthy Participants
A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of SRN-001 in Healthy Participants
Source: ClinicalTrials.gov · Last updated 4 Nov 2024
Brief summary (registry, in English)
SRN-001 is a novel small interfering RNA (siRNA) drug being developed to treat fibrosis using Self Assembled Micelle inhibitory ribonucleic acid (SAMiRNA™) technology. Amphiregulin (AREG) is a growth factor involved in fibroblast proliferation and myofibroblast transformation which is the hallmark of fibrosis in lung and kidney tissues. AREG is a downstream gene overexpressed by Transforming growth factor-β (TGF-β) during fibrosis, promoting fibroblast to myofibroblast transition (FMT). SRN-001 is designed to downregulate generating amphiregulin by RNA interference (RNAi). The goal of this clinical trial is to evaluate safety, tolerability, and pharmacokinetics in healthy participants. This trial is first-in-human clinical trial to develop SAMiRNA™ to utilize as therapeutic use.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 26 Jul 2023
- Start date
- 8 Sept 2023
- Primary completion date
- 15 Mar 2024
- Lead sponsor
- siRNAgen Therapeutics Inc.
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT05984992
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 25
- From 8 Sept 2023 to the primary completion date, 15 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant surgical history within 1 year
- Positive screen for alcohol or drugs of abuse
- Who have received an investigational agent within 3 months, or 5 half-lives
- Who have used prescription medication within 4 weeks including vaccines
- Who have used OTC medication within 7 days
- With clinically relevant wounds, following a clinically relevant surgery or have recently completed any invasive procedures (ie, Endoscopy) within 1 week, or who are scheduled for an elective surgical procedure
Other illness
- Who is with history of multiple drug allergies or history of allergic reaction to an oligonucleotide or common medicine (eg, aspirin, antibiotics, etc) or clinically significant hypersensitivity
- History of drug abuse or alcoholism within 2 years, and a restriction of consuming alcohol during study period
- HBsAg, Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV infection
- Who have a significant infection or known inflammatory process ongoing
- Any conditions that, in physician's opinion, would make the participant unsuitable for enrollment or could interfere with the participant's participation
Lab values
- Liver function test is 1.5 times greater than upper limit of normal (ULN)
- Albumin ≥ 35 g/L and ≤ 50 g/L
- Hb \< 115 g/L (female), \< 125 g/L (male)
- estimated glomerular filtration rate (eGFR) \< 60 mL/min (CKD-EPI), 90 mL/min (MDRD)
- Glucose \< 3 mmol/L
Other
- Who has clinically significant history
- No tolerance to IV injections or significant potential of intolerance
- Pregnant or lactating females
- QTcF \> 450 msec for male, \> 470 msec for female
- Inappropriate lab result by physician's discretion
- Who have donated \> 500 mL of blood within 3 months
Who the study is looking for
- Age 18-70
- BMI ≥18.0 kg/㎡ and ≤35 kg/㎡
- 12-lead triplicate electrocardiogram (ECG) readings within normal limits or with no clinically significant abnormalities
- systolic blood pressure ≥ 90 mmHg and ≤160 mmHg; a diastolic blood pressure ≥ 50 mmHg and ≤95 mmHg; pulse ≥ 45 bpm and ≤100 bpm; tympanic temperature ≥ 35.5°C and ≤37.7°C and respiratory rate 12rpm to 22rpm
- Negative urinary cotinine
- Compliance to contraception and sperm donation restriction
- Participants who are able and willing to give written informed consent
- Fully vaccinated against SARS-CoV-2
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CMAX Clinical Research Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.