Phase 1 Study for IPG11406 in Health Volunteer

NCT06255834 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IPG11406-C001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and food effect of orally administered IPG11406 in healthy adult participants

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Safety Indicators：Adverse Event

  from first dose until end of follow-up, up to 17 days

Secondary Outcomes (3)

• Pharmacokinetic Indicators: Maximum Plasma Concentration (Cmax)

  Up to 10 days

• Pharmacokinetic Indicators: Area Under the Plasma Concentration Versus Time Curve (AUC)

  Up to 10 days

• Pharmacokinetic Indicators:Time to Maximum Concentration (Tmax)

  Up to 10 days

Study Arms (9)

Cohort 1 (SAD - 0.5 mg)

EXPERIMENTAL

4 subjects in this cohort will receive a single dose of IPG11406 0.5 mg qd and 2 subjects will receive a single dose of placebo 0.5 mg qd orally.

Drug: IPG11406

Cohort 2 (SAD - 2 mg)

EXPERIMENTAL

4 subjects in this cohort will receive a single dose of IPG11406 2 mg qd and 2 subjects will receive a single dose of placebo 2 mg qd orally.

Drug: IPG11406

Cohort 3 (SAD - 6 mg)

EXPERIMENTAL

4 subjects in this cohort will receive a single dose of IPG11406 6 mg qd and 2 subjects will receive a single dose of placebo 6 mg qd orally.

Drug: IPG11406

Cohort 4 (SAD - 20 mg)

EXPERIMENTAL

6 subjects in this cohort will receive a single dose of IPG11406 20 mg qd and 2 subjects will receive a single dose of placebo 20 mg qd orally.

Drug: IPG11406

Cohort 5 (SAD - 40 mg)

EXPERIMENTAL

6 subjects in this cohort will receive a single dose of IPG11406 40 mg qd and 2 subjects will receive a single dose of placebo 40 mg qd orally.

Drug: IPG11406

Cohort 6 (SAD - 80 mg)

EXPERIMENTAL

6 subjects in this cohort will receive a single dose of IPG11406 80 mg qd and 2 subjects will receive a single dose of placebo 80 mg qd orally.

Drug: IPG11406

Cohort 7 (MAD - 10 mg)

EXPERIMENTAL

6 subjects in this cohort will receive a dose of IPG11406 10 mg qd and 2 subjects will receive a dose of placebo 10 mg qd orally from Day 1 to 10-day.

Drug: IPG11406

Cohort 8 (MAD - 20 mg)

EXPERIMENTAL

6 subjects in this cohort will receive a dose of IPG11406 20 mg BID and 2 subjects will receive a dose of placebo 20 mg BID orally from Day 1 to 10-day.

Drug: IPG11406

Cohort 9 (MAD - 40 mg)

EXPERIMENTAL

6 subjects in this cohort will receive a dose of IPG11406 40 mg qd and 2 subjects will receive a dose of placebo 40 mg qd orally from Day 1 to 10-day.

Drug: IPG11406

Interventions

IPG11406 DRUG

IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 0.5 mg, 10 mg and 40 mg Storage：15 \~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 or placebo tablets are orally administered once on Day 1 (Part A) or daily for 10 days from Day 1 to Day 10 (Part B) in a fasted state. Oral doses will be administered with 240 ml of water. Tablets should not be chewed or crushed. Participants in the FE Cohort will receive a second single dose of IPG11406 following a standardized high fat meal upon ≥4 days washout period after the first dose. IPG11406 Placebo Placebo tablets: tablets identical to IPG11406 tablets

Also known as: IPG11406 Placebo

Cohort 1 (SAD - 0.5 mg); Cohort 2 (SAD - 2 mg); Cohort 3 (SAD - 6 mg); Cohort 4 (SAD - 20 mg); Cohort 5 (SAD - 40 mg); Cohort 6 (SAD - 80 mg); Cohort 7 (MAD - 10 mg); Cohort 8 (MAD - 20 mg); Cohort 9 (MAD - 40 mg)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria to be included in the study:
• Demography
• Healthy volunteers aged between 18 and 50 years old, both male and female, are required. Participants must undergo medical history investigation, physical examination, vital signs examination, electrocardiogram, chest X-ray examina-tion, and laboratory tests during the screening period to ensure good health.
• The body mass index (BMI) is between 18 and 32, calculated as: BMI= weight(kg)/ height 2(m 2);
• Participants were required to be in a non-menstrual, non-pregnant, and non-lactating period during the trial and to agree to have no childcare plans for the next 6 months.
• Physical health, defined as: detailed and clear medical history, comprehensive physical examination (including blood pressure and pulse rate, laboratory tests, and 12-lead electrocardiogram) with no clinical abnormalities detected;
• After 10 minutes of supine position testing, vital signs should be within the following range: 95 mmHg \<systolic blood pressure (SBP) \<140 mmHg 45 mmHg \<Diastolic Blood Pressure (DBP) \<90 mmHg 45 bpm \<Heart Rate (HR) \<90 bpm
• After 10 minutes of resting supine position, 12-lead ECG readings: PR interval\<120 ms \<220 ms, QRS complex \<120 ms, QTc (Fridericia recommendedalgorithm) ≤450 ms, normal ECG; or abnormal ECG results deemed clinically insignificant by the investigator.
• Laboratory test results must fall within the normal range (or within the established screening threshold) or show no clinically significant abnormalities; however, serum creatinine, alkaline phosphatase, and liver enzymes (aspartate aminotransferase,Alanine aminotransferase (ALT) should not exceed the upper limit of the laboratory normal range. Total bilirubin should not exceed 1.5 times the upper limit of the normal range for conjugated bilirubin (unless the subject has a history of Gilbert syndrome).
• Willing and able to comply with all treatment, and laboratory testing protocols, agree to take the oral test medication, and meet other study requirements
• Contraceptive requirements for female subjects:
• Fertile female participants: Must undergo a urine pregnancy test during the screening period with a negative result, and agree to use effective contraception for 3 months after signing the informed consent until the last dose of the investigational drug. Contraception must always be strictly followed according to the instructions of the contraceptive product and the investigator. Effective contraception includes: complete abstinence, intra- uterine device (IUD) or intrauterine contraceptive system (IUS), double- barrier method (e.g., spermicide plus male condom, female condom, diaphragm, cervical cap, or intrauterine device), or a partner who has undergone vasectomy and whose semen cannot be detected for sperm. b. Fertile women: This includes postmenopausal women (with complete cessation of menstruation for ≥1 year) or women with surgical records of hysterectomy, bilateral oophorectomy, or bilateral salpingectomy (as opposed to tubal ligation). Fertile women do not need to adhere to the listed contraceptive measures. 10. Contraceptive requirements for male subjects: Male subjects must agree to use the listed effective contraceptive methods or have undergone vasectomy within 3 months after signing the informed consent and receiving the last dose ofthe investigational drug. 11. Participants must provide informed consent for this study prior to enrollment and voluntarily sign a written informed consent form.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from the study:
• Medical history and clinical status

Sponsors & Collaborators

• Nanjing Immunophage Biotech Co., Ltd: lead
• Zhejiang Hospital: collaborator

Study Sites (1)

Zhejiang Hospital

Hangzhou, Zhejiang, 310013, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: WangJianfei/CSO
• Organization: Immunophage

jfwang@immunophage.com.cn

+8602134782827

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: February 13, 2024
• Study Start: February 24, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)