A First-in-human, Single-ascending-dose Study of IBI3033 in Healthy Participants

Innovent Biologics

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: IBI3033

Study type: Interventional

Funder types: Industry

Identifiers

NCT07311226

CIBI3033A101

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

32 participants in 6 patient groups, including a placebo group

IBI3033 Dose 1 subcutaneously (SC)

Experimental group

Treatment:

Drug: IBI3033

Placebo IV

Placebo Comparator group

Treatment:

Drug: Placebo

IBI3033 Dose 3 SC

Experimental group

Treatment:

Drug: IBI3033

IBI3033 Dose 2 intravenously (IV)

Experimental group

Treatment:

Drug: IBI3033

IBI3033 Dose 2 SC

Experimental group

Treatment:

Drug: IBI3033

Placebo SC

Placebo Comparator group

Treatment:

Drug: Placebo