A Phase I Study of RC1416 Injection

NCT06067490 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: NJRJK-RC1416-Ia
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of RC1416 injection via Subcutaneous Administration in Healthy Adult Volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• Adverse Events

  incidence ,severity and relation to investigational drugs of Adverse Events according to CTCAE V5.0

  up to 92 days

• Vital Signs

  number of praticipants with clinically notable Vital Signs according to CTCAE V5.0

  up to 92 days

• Laboratory Tests

  number of praticipants with clinically notable Laboratory Tests according to CTCAE V5.0

  up to 92 days

• ECG

  number of praticipants with clinically notable Electrocardiogram(ECG) Values according to CTCAE V5.0

  up to 92 days

• Injection Site Reaction

  number of praticipants with clinically notable Injection Site Reaction according to CTCAE V5.0

  up to 4 days

Secondary Outcomes (4)

• Pharmacokinetics-Cmax

  up to 92 days

• Pharmacokinetics-AUC 0-t

  up to 92 days

• Pharmacokinetics-AUC 0-inf

  up to 92 days

• Anti-Drug antibody (ADA)

  up to 92 days

Study Arms (2)

RC1416

EXPERIMENTAL

RC1416(SAD),single ascending (25mg-600mg) of RC1416 by subcutaneous injection

Drug: RC1416(SAD)

Placebo

PLACEBO COMPARATOR

Placebo(SAD), Each subjects will receive the placebo once by subcutaneous injection.

Drug: Placebo(SAD)

Interventions

RC1416(SAD) DRUG

RC1416(SAD),there are six doses(25mg-600mg) in this part. Each subjects will receive the drug once by subcutaneous injection.

Also known as: RC1416

RC1416

Placebo(SAD) DRUG

Placebo(SAD), Each subjects will receive the placebo once by subcutaneous injection.

Also known as: RC1416 Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female aged 18 to 50 years(including the boundary value)，Chinese.
• Male Weight of 50 kg to 90 kg，femal weight of 40kg to 90kg, and BMI of 19.0 to 28.0 kg/m2 (including the boundary value).
• Subject have no fertility, sperm/egg donation plan for at least 6 months from the signing of the informed consent to the end of the treatment, and voluntarily takes medically recognized effective non-drug contraceptive measures (including his partner) during the trial.

You may not qualify if:

• Have participated in clinical trials of drugs in other trials within 3 months prior to screening .
• With clinically significant investigator-identified abnormalities of the cardiovascular, respiratory, digestive, endocrine systems (e.g., diabetes), nervous/mental systems, blood, and lymphatic systems (immune deficiency), and musculoskeletal systems.
• With clinically significant infectious disease (e.g., cellulitis, abscess, or systemic infection (e.g., sepsis), or history of clinically significant opportunistic infection (e.g.,invasive candidiasis or pneumocystis pneumonia) within 3 months before to screening.
• With a history of active tuberculosis or the presence of latent tuberculosis infection or active tuberculosis indicated by any current symptoms, signs or laboratory tests.
• Have an allergic constitution, history of allergy to the test drug ingredient or to any drug or food or pollen.
• Received chemotherapy, radiotherapy, immunosuppressive therapy, or high-dose corticosteroid treatment within 5 years before signing the informed consent.
• Use of any prescription, OTC, traditional Chinese medicine, vitamin or health product within 1 month prior to screening;
• Received live or attenuated vaccines within 1 month or have any vaccination schedule during the clinical trial.
• Had surgery within 6 months prior to screening or planned surgery during the trial.
• Have difficulty with venous blood collection, or subjects who faint at the sight of blood or a needle, or have difficulty with subcutaneous administration.
• Have lost or donated blood for more than 400 mL(not including menstrual blood loss )or received blood transfusion or using blood products within 3 months before signing informed consent or planning to donate blood during the study or within 1 month after the trial.
• Excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups per day, 250 mL per cup) within 6 months prior to screening.
• Have consumed any beverage or food containing grapefruit or caffeine (such as grapefruit juice, coffee, strong tea, chocolate, caffeinated carbonated beverages, cola, cocoa, etc.) in the 48 hours prior to screening.
• Have special dietary requirements and cannot comply with a unified diet.
• Smoked ≥5 cigarettes per day within 3 months prior to screening or or could not guarantee to quit smoking during the trial.

Sponsors & Collaborators

• Nanjing RegeneCore Biotech Co., Ltd.: lead

Study Sites (1)

China-japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Study Officials

• Li J Tong, Doctor

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 5, 2023
• Study Start: June 29, 2023
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: December 2, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)