A First-in-human, Single-ascending-dose Study of IBI3033 in Healthy Participants
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of IBI3033 in Healthy Participants
1 other identifier
interventional
32
1 country
1
Brief Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single 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, 1-day treatment period and 12-week follow-up period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2025
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
December 16, 2025
CompletedStudy Start
First participant enrolled
December 23, 2025
CompletedFirst Posted
Study publicly available on registry
December 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 30, 2025
December 1, 2025
6 months
December 16, 2025
December 16, 2025
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 85
Secondary Outcomes (4)
PK parameter: Cmax
Baseline to Day 85
PK parameter: tmax
Baseline to Day 85
PK parameter: AUC
Baseline to Day 85
Immunogenticity profiles
Baseline to Day 85
Study Arms (6)
IBI3033 Dose 1 subcutaneously (SC)
EXPERIMENTALPlacebo IV
PLACEBO COMPARATORIBI3033 Dose 3 SC
EXPERIMENTALIBI3033 Dose 2 intravenously (IV)
EXPERIMENTALIBI3033 Dose 2 SC
EXPERIMENTALPlacebo SC
PLACEBO COMPARATORInterventions
Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.
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
December 16, 2025
First Posted
December 30, 2025
Study Start
December 23, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 30, 2025
Record last verified: 2025-12