Study of YOLT-202 in the Treatment of Alpha-1 Antitrypsin Deficiency (AATD)
NCT07193615 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-09-26
Summary
This is a single-arm, open-label, single-dose, dose-escalation exploratory study to evaluate the safety and tolerability of a single dose of YOLT-202 in patients with AATD and determine the optimal biologically active dose (OBD) of YOLT-202.
Conditions
- Alpha-1 Antitrypsin Deficiency (AATD)
Interventions
- DRUG
-
YOLT-202
The IP is administered intravenously at the predetermined dose; Administration frequency: Once
Sponsors & Collaborators
-
RenJi Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-18
- Primary Completion
- 2027-01-31
- Completion
- 2027-03-31
Countries
- China
Study Locations
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