A Mutiple-dose Study of IBI3033 in Healthy Participants
A Randomized, Double-blind, Placebo-controlled, Mutiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of IBI3033 in Healthy Participants
1 other identifier
interventional
8
1 country
1
Brief Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3033 in Chinese healthy participants. The entire trial cycle includes a 4-week screening period, 8-week treatment period and 8-week follow-up period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2026
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2026
CompletedFirst Posted
Study publicly available on registry
March 9, 2026
CompletedStudy Start
First participant enrolled
March 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 13, 2026
March 9, 2026
March 1, 2026
6 months
February 27, 2026
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events (AEs)/serious adverse events (SAEs)
Percentage of participants who have experienced AEs/SAEs
Baseline to Day 113
Secondary Outcomes (4)
PK parameter: Cmax
Baseline to Day 113
PK parameter: tmax
Baseline to Day 113
PK parameter: AUC
Baseline to Day 113
Immunogenticity profiles
Baseline to Day 113
Study Arms (3)
Placebo SC
PLACEBO COMPARATORParticipants in placebo group will receive placebo SC.
IBI3033 Dose 2 SC
EXPERIMENTALParticipants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.
IBI3033 Dose 1 subcutaneously (SC)
EXPERIMENTALParticipants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males/females aged 18-55 years (inclusive).
- BMI 18.0-28.0 kg/m²; weight ≥50 kg (male) or ≥45 kg (female).
- Willing to use effective contraception for 6 months post-dosing.
You may not qualify if:
- History of blood or needle sickness, or those who cannot tolerate venipuncture.
- Female participants who are pregnant or breastfeeding at screening or randomization.
- History of severe infection or significant injury within 6 months, or surgery within 3 months, or any infection requiring systemic medication within 1 month prior to screening.
- History of live or attenuated vaccination within 1 month prior to screening, or those who plan to be vaccinated during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2026
First Posted
March 9, 2026
Study Start
March 24, 2026
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
November 13, 2026
Last Updated
March 9, 2026
Record last verified: 2026-03