None listed
Conditions
Brief summary
A Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in healthy, overweight and obese participants to investigate safety, tolerability and pharmacokinetics of KAI-9531 subcutaneous injection.This is a randomized, double-blind, placebo-controlled single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of a single subcutaneous (SC) administration of KAI-9531 at increasing dose levels from 1 mg to 6 mg.The purpose of the study is to examine the safety, tolerability and PK of KAI-9531 in a non-Asian and Asian population.
Interventions
This is a randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of a single subcutaneous (SC) administration of KAI-9531 at increasing dose levels from 1 to 3 mg. The purpose of the study is to examine the safety, tolerability and PK of KAI-9531 in a non- Asian and Asian population.
Participants will attend the study site between Day -28 to Day -2 (inclusive) for a screening visit. After screening, eligible parti
This is a randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of a single subcutaneous (SC) administration of KAI-9531 at increasing dose levels from 1 to 3 mg. The purpose of the study is to examine the safety, tolerability and PK of KAI-9531 in a non- Asian and Asian population. Participants will attend the study site between Day -28 to Day -2 (inclusive) for a screening visit. After screening, eligible participants will return to the study site on Day -1 and will be confined until discharge on Day 4 (72 hours). Participants will return to the study site for follow-up visits on Days 5, 6, 8, 14, 22 and Day 29. KAI-9531 is in clinical development. The method of administration is subcutaneous injection. Upto 50 participants will be enrolled across a total of 5 cohorts. Cohort 1, 2, 3 and 5 will enroll up to 10 (male or female) participants with 8 participants randomized to receive a single SC dose of KAI-9531 and 2 participants randomized to receive placebo. Cohorts 4A and 4B will enroll up to 5 participants each with 4 randomized to receive KAI-9531 and 1 participant randomized to receive placebo. Cohorts 1 to 4A and 4B will consist of participants of non-Asian descent while Cohort 5 will consist of participants of Asian descent. To sequentially escalate to the next cohort dose the PI (or delegate), in consultation with the Medical Monitor (if required) and Sponsor Medical Representative (SMR) will perform safety review in accordance with the Safety Review Committee (SRC) Charter. KAI-9531 will be administered at the following dose levels via SC injection: - Cohort 1 - 1 mg - Cohort 2 - 2 mg - Cohort 3 - 3 mg - Cohort 4A- 2 mg - Cohort 4B (males only)- 3 mg - Cohort 5 – 2 mg Placebo will contain excipients in water, without active ingredient. Study drug will be administered at the study site by trained study site personnel to ensure compliance.
Sponsors
Kailera Therapeutics
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects. 2. Are of non-Asian descent and do not identify as being of Asian origin. Asians are defined in this study as participants self-identifying as originating from: Far East, Southeast Asia, or the Indian subcontinent, including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, Vietnam, Mongolia, North Korea, South Korea and Taiwan or having parents or grandparents originating from Asian countries. 3. Body mass index greater than or equal to 22.0 and lesser than or equal to 35.0 kg/m2, with a body weight greater than or equal to 60 kg and lesser than or equal to 130 kg at screening and check-in on Day -1. 4. Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without clinically significant abnormalities. 5. Willing and able to comply with modified food and eating habits that reduce nausea and vomiting for this class of drug.
Exclusion criteria
1. Known hypersensitivity to the study drug or any of the study drug ingredients. 2. History of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer’s ability to participate in the study (including but not limited to those with a with known allergy to GLP-1 and/or GIP receptor agonists and their excipients). 3. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months determined by the PI (or delegate) to be clinically relevant. 4. History of surgery or hospitalization prior to screening (1 month prior for minor surgery and 3 months prior for all other surgery), or surgery planned during the study or history of bariatric surgery (at any time). 5. Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma). 6. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia. 7. History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia. 8. Presence or having sequelae of gastrointestinal, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. 9. A history of or positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
Outcome results
None listed