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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07311226

Enrollment

Registered

2025-12-30

Start date

2025-12-31

Completion date

2026-06-30

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

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.

Interventions

DRUGPlacebo

Participants in placebo group will receive placebo SC/IV.

DRUGIBI3033

Participants in IBI3033 group will receive a signle dose of IBI3033 at the protocol specified dose SC/IV.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy males/females aged 18-55 years (inclusive). 2. BMI 18.0-28.0 kg/m²; weight ≥50 kg (male) or ≥45 kg (female). 3. Willing to use effective contraception for 6 months post-dosing.

Exclusion criteria

1. History of blood or needle sickness, or those who cannot tolerate venipuncture. 2. Female participants who are pregnant or breastfeeding at screening or randomization. 3. 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. 4. History of live or attenuated vaccination within 1 month prior to screening, or those who plan to be vaccinated during the study.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse events (AEs)/serious adverse events (SAEs)	Baseline to Day 85	Percentage of participants who have experienced AEs/SAEs

Secondary

Measure	Time frame	Description
PK parameter: Cmax	Baseline to Day 85	Observed maximum plasma concentration of IBI3033
PK parameter: tmax	Baseline to Day 85	Time to achieve Cmax of IBI3033
PK parameter: AUC	Baseline to Day 85	Area under the plasma concentration-time curve of IBI3033
Immunogenticity profiles	Baseline to Day 85	Frequency of anti-drug antibody (ADA) of IBI3033

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026