NCT07836452RecruitingPhase 1
A Phase 1, First-in-Human Study of CITY-RBP4 in Healthy Volunteers and STGD1 Participants
A Phase 1, Randomized, Double-Masked, Placebo-Controlled, Single-Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CITY-RBP4 Administered Subcutaneously in Healthy Volunteers and Participants With Stargardt Disease Type 1 (STGD1)
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
This is a first-in-human (FIH), multicenter, randomized, double-masked, placebo-controlled adaptive clinical study evaluating the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of CITY-RBP4, following single-ascending doses and multiple doses, via subcutaneous (SC) administration.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 16 Sept 2026
- Start date
- Sept 2026
- Primary completion date
- Feb 2028
- Lead sponsor
- City Therapeutics
- NCT number
- NCT07836452
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 48
- From Sept 2026 to the primary completion date, Feb 2028
- 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 ocular disease or prior ocular surgery that could interfere with safety assessments
- Prior RNAi/oligonucleotide therapy or recent investigational treatment
- Recent vitamin A-related supplements, retinoids, or medications affecting vitamin A metabolism
- Prior ocular gene therapy, stem cell therapy, or retinal implant
Other illness
- History of vitamin A deficiency, malabsorption, or chronic diarrhea
- Clinically significant cardiac, hepatic, renal, pulmonary, neurologic, or psychiatric disease
- Positive hepatitis B, hepatitis C, or HIV screening
- Ocular conditions that could confound retinal imaging or safety evaluation
- Clinically significant non-ophthalmic disease, abnormal screening labs/ECG, or positive hepatitis B, hepatitis C, or HIV screening
Other
- Pregnancy or breastfeeding, if applicable
- Vitamin A deficiency or recent prohibited vitamin A-related treatments
- Recent interventional study participation
- Pregnancy or breastfeeding, if applicable
Who the study is looking for
- Willing and able to provide written informed consent form
- Be aged 18 to 45 years (inclusive) at the time of signing the informed consent form
- Generally healthy on medical history, exam, labs, and ECG
- BCVA 20/25 or better in each eye
- Serum retinol above protocol threshold
- Body weight ≥40 kg and BMI of 18.0 to 32.0 kg/m2
- Men and WOCBP must agree to use highly effective methods of contraception or practice abstinence from 30 days before the first dose of CITY-RBP4, throughout the study, and for at least 180 days after treatment with CITY-RBP4 or the last study visit, whichever is longer; men must refrain from donating or banking sperm during the same period
- Female participants who are not WOCBP should meet at least 1 of the following criteria: have undergone a documented hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy; have medically confirmed ovarian failure, or achieved postmenopausal status
- Participants aged 12 to 45 years
- Clinical diagnosis of STGD1 with documented ABCA4 pathogenic/likely pathogenic variant
- Minimum BCVA is required in the study eye
- Subjects must have a defined aggregate atrophic lesion in 1 or both eyes
- Body weight ≥40 kg
- Able to complete key ophthalmic safety assessments and comply with study precautions
Age in the registry: 12 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nucleus Network Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.