A Study to Evaluate Safety, Tolerability and pK of Semaglutide ER Injectable Suspension in Healthy, Adult Human Subjects

NCT06422624 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 15403/23-24
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the trail is to evaluate the safety, tolerability and pharmacokinetics of a single escalated doses of semaglutide extended-release injectable suspension in healthy adult, human study participants under fasting condition.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum plasma concentration

  From time zero up to the last time point with measurable concentration

• AUC0-t

  Area under the plasma concentration time curve from time zero to the last measurable concentration

  From time zero up to the last time point with measurable concentration

• AUC0-inf

  Area under the plasma concentration-time curve from time zero to infinity

  From time zero up to the last time point with measurable concentration

Study Arms (3)

Semaglutide ER Injectable Suspension, 1 mg

EXPERIMENTAL

Participants receive a single of semaglutide ER injectable suspension at a lower dose 1 mg for safety, tolerability and pharmacokinetics assessements

Drug: Semaglutide Extended-release for Injectable Suspension, 1 mg

Semaglutide ER Injectable Suspension, 4 mg

EXPERIMENTAL

Participants receive a single of semaglutide ER injectable suspension at a medium dose 4 mg for safety, tolerability and pharmacokinetics assessements

Drug: Semaglutide Extended-release for Injectable Suspension, 4 mg

Semaglutide ER Injectable Suspension, 8 mg

EXPERIMENTAL

Participants receive a single of semaglutide ER injectable suspension at a higher dose 8 mg for safety, tolerability and pharmacokinetics assessements

Drug: Semaglutide Extended-release for Injectable Suspension, 8 mg

Interventions

Semaglutide Extended-release for Injectable Suspension, 1 mg DRUG

Singel-dose; Subcutaneous

Semaglutide ER Injectable Suspension, 1 mg

Semaglutide Extended-release for Injectable Suspension, 4 mg DRUG

Singel-dose; Subcutaneous

Semaglutide ER Injectable Suspension, 4 mg

Semaglutide Extended-release for Injectable Suspension, 8 mg DRUG

Singel-dose; Subcutaneous

Semaglutide ER Injectable Suspension, 8 mg

Eligibility Criteria

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

You may qualify if:

• He/She should provide written informed consent.
• He/She must be a healthy adult human male or non-pregnant, non-lactating females,18 - 45 years of age (both years inclusive).
• He/She should have a body mass index ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 with body weight at least 55 kg for men and at least 48 kg for women.
• He/She should have a baseline systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 100 mm Hg. Similarly baseline diastolic blood pressure with upper limit less than 90 mm Hg and lower limit more than or equal to 60 mmHg.
• He/She should have pulse rate not less than 60 beats/min and not more than 100 beats/min and respiratory rate not less than 14 breaths/min and not more than 18 breaths/min.
• He/She must be of normal health as determined by medical history (including medication history) and physical examination performed within 21 days prior to the dosing.
• He/She should have normal ECG, chest X-ray and vital signs.
• He/She should have normal or clinically non-significant thyroid function tests (T3, T4 and TSH).
• Availability of a study volunteer for the entire study duration and willingness to adhere to protocol requirements as evidenced by written informed consent.
• If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence for the duration of the study as judged by the investigator(s), or If she is postmenopausal with spontaneous amenorrhea for at least 01 year. or If she is surgically sterile (had a bilateral tubal ligation, bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 06 months).

You may not qualify if:

• He/She is incapable of understanding the informed consent.
• He/She has a history of hypersensitivity (e.g. anaphylactic reactions, angioedema and serious skin reactions) or idiosyncratic reaction to active or inactive ingredient in the Semaglutide extended-release injectable suspension or any other related drugs.
• He/She has a history of impairment of renal, hepatic, cardiac, pulmonary or gastrointestinal function.
• He/She has a history of tuberculosis, epilepsy, asthma, diabetes, psychosis and eye disorders.
• He/She has history of any pulmonary disorder (COPD, Asthma, Bronchitis, other respiratory disorders) and skin related disorders.
• He/She has a personal or family history of Medullary Thyroid Carcinoma (MTC) or any other thyroid tumors or Multiple Endocrine Neoplasia 2 (MEN 2) or any other endocrine disorders.
• He/She has a history of pancreatitis, diabetic retinopathy, gall bladder disease.
• He/She has undergone surgery within the past 3 months prior to screening, or those planning to undergo surgery during the trial period.
• He/She has any difficulty in swallowing.
• He/She regularly smokes more than 10 cigarettes daily or has difficulty in abstaining from tobacco for the entire study duration.
• He/She has taken over the counter or prescribed medications, including vitamins, herbal supplements, insulin or drugs which promote insulin secretion, Sulfonylureas, any oral medications or any systemic medication within the past 30 days prior to dosing.
• He/She has a history of any psychiatric illness, which may impair the ability to provide written, informed consent.
• He/She has a history of alcohol or substance abuse within the last 05 years.
• He/she using prohibited medications (e.g., sedative hypnotics, CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating antiepileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants).
• He/She has clinically significant abnormal values of laboratory parameters.

Sponsors & Collaborators

• Bostal Drug Delivery Co., Ltd: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: August 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05