A Two-Part First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295

NCT06144684 | Completed Phase 1

• 2 other identifiers: GUC17-011008236
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-part, single centre, double-blind (within cohorts), randomised, placebo-controlled, single (Part 1) and multiple (Part 2) ascending subcutaneous dose study in lean to overweight or obese but otherwise healthy men (Part 1) and men and non-pregnant, non-lactating women (Part 2). The primary objective is to assess the safety and tolerability. Secondary objectives are to characterize the pharmacokinetics (PK) and to investigate pharmacodynamic effects.

Conditions

Healthy Volunteers; Overweight

Keywords

Weight management

Outcome Measures

Primary Outcomes (3)

• Safety - Adverse Events (AE) incidence

  To provide safety information for GUB014295 by assessing: incidence of AEs categorized in System Organ Class (SOC) according to MedDRA (and evaluating severity and duration for SOC). No formal hypothesis will be tested in the study. Descriptive summaries for all safety safety data for all placebo, each active treatment and all active will be provided (including changes from baseline)

  from baseline (day 0) to end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

• Safety - changes in vital signs

  To provide safety information for GUB014295 by assessing: Any changes from baseline for vital signs including: Blood pressure, Pulse/heart rate, oral temperature and respiratory frequency summarized as a ratio (baseline/end of trial). No formal hypothesis will be tested in the study. Descriptive summaries (as a relative change (ratio: 0 - 1) from day 0 to end of trial) for all safety safety data for all placebo, each active treatment and all active will be provided.

  from baseline (day 0) to end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

• Safety - Safety laboratory parameters

  To provide safety information for GUB014295 by assessing a wide range of laboratory parameters within hematology, coagulation, clinical chemistry, virology, urinalysis. No formal hypothesis will be tested in the study. Descriptive summaries (as a relative change (ratio: 0 - 1) from day 0 to day end of trial)) for all safety safety data for all placebo, each active treatment and all active will be provided.

  From baseline (day 0) to end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

Secondary Outcomes (5)

• Pharmacokinetic (PK) - Tmax and Cmax

  from dosing (day 0) until maximum concentration after final dose

• Pharmacokinetic (PK) - area under the concentration curve (AUC)

  From dosing (day 0) until end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

• Pharmacokinetic (PK) - T1/2

  from dosing (day 0) until end of trial (day 29)part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

• Pharmacokinetic (PK) - CL/F

  from dosing (day 0) until end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

• Pharmacokinetic (PK) - Vz/F

  From dosing (day 0) until end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

Other Outcomes (2)

• Pharmacodynamic - body weight

  From baseline (day 0) until end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

• Pharmacodynamic - liquid meal test incl. paracetamol (Part 1, Part 2A & Part 2B)

  Before dosing (day -1) and day 4 part 1, day-1 and day 39 part 2A and day-1 and day 81 part 2B

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo solution

Drug: GUB014295-PLACEBO

GUB014295

ACTIVE COMPARATOR

GUB014295 solution 5 mg/mL

Drug: GUB014295

Interventions

GUB014295 DRUG

GUB014295 is a long-acting amylin analogue in development, a single subcutaneous dose is administered in part 1, multiple doses administered in part 2 of the study

Also known as: GUBamy

GUB014295

GUB014295-PLACEBO DRUG

GUB014295-PLACEBO is matching GUB014295 in appearance, a single subcutaneous dose is administered in part 1, multiple doses administered in part 2 of the study

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males (Part 1 only) aged 18 to 55 years, and males and females (Part 2 only) aged 18 to 65 years inclusive at the time of signing informed consent
• Must agree to adhere to the contraception requirements
• Lean to overweight or obese but otherwise healthy males (Part 1 and 2) or nonpregnant, non-lactating females (Part 2 only)
• BMI of 22.0 to 32.0 kg/m2 for Part 1 and Part 2A, and a BMI of 27.0 to 35.0 kg/m2 for Part 2B and Part 2C, as measured at screening. Overweight or obese as assessed by BMI should be due to excess adipose tissue, as judged by the investigator
• Weight for males ≥70 kg (all parts), and for females ≥60 kg (Part 2 only) at screening

You may not qualify if:

• Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
• Known or suspected hypersensitivity or allergy to paracetamol
• Presence or history of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric, malignant, metabolic, endocrinological, haematological or venereal disorder, as judged by the investigator
• Presence or history of any clinically relevant gastrointestinal diseases or symptoms of gastrointestinal disorders potentially affecting interpretation of study data.
• Presence or history of diseases associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)
• History of major depressive disorder within 2 years prior to screening
• Subjects unable to take paracetamol for any reason
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
• Subjects with tattoos or scars on the abdomen which may interfere with injection site assessments as determined by the investigator or delegate at screening
• Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed.
• HbA1c ≥48 mmol/mol (≥6.5%) and/or fasting plasma glucose ≥7.0 mmol/L at screening
• Part 2B only: Subjects with haemoglobin \<LLN at screening and/or admission
• Prolongation of the QTcF over 450 msec for males and 470 msec for females or any other clinically significant abnormal ECG results as judged by the investigator
• Supine blood pressure (after ≥5 min rest) \<90 mmHg or \>150 mmHg (systolic) and/or \<50 mmHg or \>90 mmHg (diastolic)

Sponsors & Collaborators

• AbbVie: lead
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sharan Sidhu

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study; each cohort will include matching placebo and active drug solutions.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This phase 1 study, will be conducted to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending subcutaneous doses of GUB014295

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 22, 2023
• Study Start: November 29, 2023
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

GB (1)