Evaluation of Safety, Tolerability, PK/PD, and Metabolism of Single-Dose Singletine(DC407) in Adults

NCT06160401 | Completed Phase 1

• 1 other identifier: JYC0101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of Singletine in healthy adult subjects. The main questions it aims to answer are: safety and tolerability of Singletine in healthy subjects, the pharmacokinetic characteristics after single and multiple doses and the effect of food on the pharmacokinetic characteristics. Participants will be treated with Singletine orally and safety and pharmacokinetic evaluations will be conducted according to the protocol.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Assessment by adverse event monitoring CTCAE 5.0

  First dose of study drug up to 31 days after last dose of study drug

Secondary Outcomes (2)

• Area Under the Curve（AUC） From Time Zero to Last Quantifiable Concentration

  Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72 hours following single dose administration;

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72 hours following single dose administration;

Study Arms (4)

Singletine（DC407） ascending dose

EXPERIMENTAL

Single ascending dose

Drug: Singletine

Singletine（DC407）food influence group

EXPERIMENTAL

Food influence group

Drug: Singletine

Singletine placebo comparator(Single ascending dose)

PLACEBO COMPARATOR

Single ascending dose

Drug: Placebo

Singletine placebo comparator(food influence group)

PLACEBO COMPARATOR

Food influence group

Drug: Placebo

Interventions

Singletine DRUG

Singletine orally administered

Also known as: Singletine（DC407）experimental group

Singletine（DC407） ascending dose; Singletine（DC407）food influence group

Placebo DRUG

Placebo orally administered

Also known as: Placebo group

Singletine placebo comparator(Single ascending dose); Singletine placebo comparator(food influence group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 years old (including both endpoints), healthy males or females;
• Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19-28 kg/m2 (including both endpoints);
• No significant abnormal clinical symptoms, normal physical examination, vital signs, 12-lead electrocardiogram (ECG), chest CT, ultrasound, and important indicators in laboratory tests show no clinically significant abnormalities;
• Subjects (including partners) have no parenting plans within 90 days from screening to the last administration of the study drug and voluntarily adopt appropriate and effective contraceptive measures (non-oral contraceptives);
• Have a full understanding of this study, voluntarily participate in the trial, and voluntarily sign the written informed consent form.

You may not qualify if:

• Pregnant or lactating women;
• Subjects with special dietary requirements who cannot adhere to a uniform diet;
• Subjects suspected or confirmed to be allergic to any component similar to the study drug or any ingredient in the study drug, or individuals with an allergic constitution;
• Subjects with past or present severe diseases/abnormalities (including but not limited to cardiac/cerebrovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatologic, malignant tumors, hematological, immunological, rheumatic, neurological or psychiatric diseases), or any acute or chronic disease or physiological condition that could interfere with the trial results;
• Subjects with severe infectious diseases within six months prior to screening, or a history of herpes zoster, disseminated herpes zoster, any infectious history judged by the investigator to likely worsen due to participation in the study, or any infectious history requiring antimicrobial treatment within two weeks after screening; or the presence of active infections, including acute and chronic infections as well as localized infections;
• Subjects with active or latent tuberculosis, or with a history of tuberculosis.

Sponsors & Collaborators

• Guangzhou JOYO Pharma Co., Ltd: lead

Study Sites (1)

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, 200020, China

Location

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: November 4, 2023
• First Posted: December 7, 2023
• Study Start: August 18, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: December 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)