A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101)

Innatus Therapeutics (Shanghai) Co., Ltd.

Status and phase: Completed; Phase 1

Conditions: IBD (Inflammatory Bowel Disease)

Treatments: Drug: INT-210 Placebo; Drug: INT-210 Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT07616791

INT-210-I101

CTR20253467 (Other Identifier)

Details and patient eligibility

About

A Phase Ⅰ, Single and Multiple Ascending Dose escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Voluteers.

Primary Objectives:

● To assess the safety and tolerability of single and multiple oral dose of INT-210 capsules in healthy adult voluteers,

Secondary Objectives:

• To assess the pharmacokinetic(PK) profile of single and multiple oral doses of INT-210 capsules in healthy adult voluteers;
• To assess the safety and tolerability of INT-210 capsulese administered under fasting and fed(high-fat-meal) conditions in healthy adult voluteers;
• To assess the effect of food on the PK profile of a single oral dose of INT-210 capsules in healthy adult voluteers;

Enrollment: 86 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female healthy voluteers
• Aged 18-45 years(inclusive),
• In good general health with no evidence of active or chronic disease; and who agree to comply with the prescribed contraceptive requirement during the trial and for 3 months after the last dose.

Exclusion criteria

• Female who are pregnant or breastfeeding; or planing pregnancy, female of chidbearing potential not using adequate contraception.
• Pre-existing significant medical conditions(cardiac, hepatic, renal, gastrointestina, etc), abnormal lab results, active infection, or history of special conditions like long QT syndrome or hypocalcemia.
• Positive screening for HIV, Hepatitis B/C or syphilis;
• Recent subject in another clinical trial;
• Recent major surgery, or significant blood loss.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 4 patient groups, including a placebo group

Single Ascending Dose from 50 mg to 800 mg

Experimental group

Description:

Single Ascending Dose

Treatment:

Drug: INT-210 Capsule

Drug: INT-210 Capsule

Drug: INT-210 Capsule

Food Effect: 400mg

Experimental group

Treatment:

Drug: INT-210 Capsule

Drug: INT-210 Capsule

Drug: INT-210 Capsule

Multiple Ascending Dose: 200 mg to 600mg

Experimental group

Description:

BID

Treatment:

Drug: INT-210 Capsule

Drug: INT-210 Capsule

Drug: INT-210 Capsule

Placebo

Placebo Comparator group

Description:

Placebo for SAD, MAD and Food Effect

Treatment:

Drug: INT-210 Placebo