Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects

A Phase I Randomized, Double-Blind, Placebo-Controlled, Single Subcutaneous or Intravenous Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI112 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04511624

Enrollment

Registered

2020-08-13

Start date

2020-08-27

Completion date

2022-07-22

Last updated

2022-09-19

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

Conditions

Healthy Subjects

Brief summary

This is a the first in human study to evaluate the safety, tolerability, PK and PD of single subcutaneous or intravenous dose of IBI112 in healthy subjects

Detailed description

In this first in human, phase 1, randomized, double-blind, placebo-controlled study, a single subcutaneous or intravenous dose of IBI112 will be administered to 46 healthy subjects.

Interventions

DRUGIBI112 dose1

Drug: IBI112 SC dose1 Drug:placebo

DRUGIBI112 dose2

Drug: IBI112 SC dose2 Drug:placebo

DRUGIBI112 dose3

Drug: IBI112 SC dose3 Drug:placebo

DRUGIBI112 dose4

Drug: IBI112 SC dose4 Drug:placebo

DRUGIBI112 dose5

Drug: IBI112 IV dose5 Drug:placebo

DRUGIBI112 dose6

Drug: IBI112 SC dose6 Drug:placebo

DRUGIBI112 dose7

Drug: IBI112 IV dose7 Drug:placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy male or female 18 to 45 years of age at the time of consent 2. BMI of 19-26Kg/m2 and weight of 50-100kg 3. Must provide written informed consent, and in the investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements

Exclusion criteria

1. Subjects who have a medical history of liver, kidney, cardiovascular, nervous / mental, gastrointestinal, respiratory, urinary, endocrine 2. Subjects who have a history of relapse or chronic infection, or a history of acute infection within 2 weeks; 3. Subjects who have previously used anti-IL-12 / 23 or anti-il-23 drugs; 4. Subjects who have clinically significant abnormalities determined by vital signs, physical examination, and laboratory measurements; 5. Subjects who are not suitable for this trial due to other reasons In the investigator' opinion

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112	Day1 to Day 113 post dose

Secondary

Measure	Time frame	Description
Maximum Concentration (Cmax) - Pharmacokinetic Assessment	Day 113	IV dose & SC dose
Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment	Day 113	SC dose
Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment	Day 113	IV dose & SC dose
Half-Life (t1/2) - Pharmacokinetic Assessment	Day 113	IV dose & SC dose
Volume of Distribution (Vd) - Pharmacokinetic Assessment	Day 113	IV dose & SC dose

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026