Diet and nutrition Nutritional, Metabolic, Endocrine
Conditions
Interventions
A single -center, Phase I, randomized, double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy
Sponsors
BaseCure Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 to 65 years, inclusive, at the time of signing the informed consent. 2. Subjects who are in good general health according to the judgment of the investigator per local guidance, eg, with no clinically relevant abnormalities based on medical history, physical examinations, neurological examinations, clinical laboratory evaluations (hematology, serum chemistry, coagulation, urinalysis), and 12-lead ECG that, in the opinion of the investigator would affect subject safety. Subjects may have well-controlled hypertension providing they have been on stable treatment for at least 3 months before screening. 3. Subjects with a BMI of greater than or equal to 30 to less than 40 kg/m at screening. 4. Self-reported stable body weight (plus or minus 5%) for at least 3 months prior to screening. 5. Male subjects are eligible to participate if they are permanently sterile by vasectomy (at least 6 months before screening, and confirmed by post-surgical sperm count [verbal confirmation by subject is acceptable]), or agree to the following during the study and for at least 90 days after the last dose of study drug: 5.1. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or 5.2. Agree to use a male condom (contraception/barrier) and be advised of the benefit for a female partner to use an acceptable, highly effective method of contraception as a condom may break or leak when having sexual intercourse. 6. Female subjects are eligible to participate if they are not pregnant or breastfeeding, subject to 1 of the following during the study and for at least 90 days after the last dose of study drug: 6.1. WOCBP, defined as women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at screening and Day -1; women of childbearing potential (WOCBP) must agree to be abstinent as their preferred or usual lifestyle or use an acceptable, highly effective contraceptive method (implant contraceptive or intrauterine device) from screening. WOCBP using an effective form of contraception (injectable contraceptive or oral contraceptive pill) must also agree to use a barrier method of contraception (male condom, female condom, or female diaphragm) OR 6.2. Menopausal women (amenorrhea for greater than 12 months) must have an elevated serum FSH level at screening (greater than or equal to 40 mIU/mL); if the FSH is not elevated, they are considered to be of childbearing potential (unless permanently surgically sterile by hysterectomy, tubal ligation, etc.). 7. Agree to abstain from sperm or egg donation through 90 days after last dose of study drug. 8. Legally and ethically capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion criteria
Exclusion criteria: 1. Clinically significant infection and/or cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the subject’s risk if he/she were to participate in the study. 2. Diagnosed with diabetes (Type 1, 2 or other forms of diabetes mellitus, excluding a history of gestational diabetes). 3. Have at least 1 laboratory value suggestive of diabetes during screening, including 1 or more of HbA1c greater than or equal to 6.5% (48 mmol/mol), fasting serum glucose greater than or equal to 126 mg/dL (7.0 mmol/L), or random glucose greater than or equal to 200 mg/dL (11.1 mmol/L). Participants with prediabetes are permitted. 4. If liver function tests (alanine aminotransferase, aspartate aminotransferase, or total bilirubin) and serum creatinine are 2.0 times ULN at screening; or if creatinine phosphokinase is 3 times ULN at screening; except subjects with Gilbert’s syndrome at screening who are permitted if all other criteria are met. 5. History of renal disease at any time in the past or abnormal kidney function tests at screening (glomerular filtration rate less than 60 mL/min/1.73 m2 as estimated using the CKD-EPI 2009 equation). 6. History of acute or chronic pancreatitis from any etiology, including but not limited to gallstone pancreatitis, at any time in the past. 7. Clinically significant allergy to any type of drug (anesthetics, antibiotics) at the discretion of the investigator, or allergy to any constituents of BC-006. If there is any history of anaphylaxis/hospitalization due to drug reaction in the past, the site should discuss further with the medical monitor, if needed. 8. Any of the following abnormalities on triplicate 12-lead ECG at screening: 8.1. PR (PR interval) greater than or equal to 210 msec 8.2. QRS (QRS complex) greater than or equal to 120 msec 8.3. QTcF (Fridericia’s corrected QT interval) greater than 450 msec (males) and greater than 470 msec (females) 8.4. In addition to the above, any clinically significant abnormality on an ECG, at the Investigator’s discretion. 9. Sitting or semi-supine (for at least 5 minutes) systolic blood pressure less than 145 mmHg at screening, confirmed by repeat. 10. Sitting or semi-supine (for at least 5 minutes) diastolic blood pressure greater than 95 mmHg at screening, confirmed by repeat. 11. Clinically significant history of orthostatic hypotension at any time in the past. 12. Presence of birthmarks, tattoos, wounds, scars, blemishes, heavy hair, or other skin conditions (such as eczema) at the planned dosing site/s that could be expected to obscure the observation of injection site reactions. 13. Use of prescription drugs (other than anti-hypertension therapy and hormonal contraceptives), over-the-counter drugs (other than paracetamol and ibuprofen), food supplements, statins, fish oil supplements, or herbal medications within 7 days or 5 half–lives, whichever is longer, prior to BC-006 dosing on Day 1, and antibiotics and systemic steroids within 30 days prior to BC-006 dosing on Day 1. Anti-hypertension therapy must be stable for at least 3 months prior to screening; more than 1 anti-hypertension therapy is permitted at Investigator’s discretion. The sponsor may allow exceptions only if the me
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence and severity of Adverse Events (AEs) measured using AE assessments from the time of BC-006 dosing through the End of Study (EOS, day 85 post-dose). 2. Incidence of laboratory abnormalities measured using hematology, serum chemistry, coagulation, and urinalysis test results, 12-lead ECG parameter. Vital signs measurements. ECG done on day -28 -2 (screening), day -1 (check-in), day 1 (dosing), day 29, and day 85 (End of Study (EOS, day 85 post-dose)/ early termination (ET). Clinical Laboratory Assessments: day -28 -2 (screening) day -1 (check-in), day 3,8,15,22,29,36,43,57,29, and 85 post -dose. 3. Physical examination findings measured on day -28, -2 (screening) day -1 (check-in), day 3 and 85 post dose. 4. Suicide risk measured using the Columbia-Suicide Severity Rating Scale (C-SSRS) on Screening day -28 -2 and Day -1 (check-in), 29,57 and Day 85 post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetics (PK) of SC doses of BC-006 in adults with obesity. Assessment pharmacokinetics (PK) parameters of BC-006, including but not limited to: AUCinf, AUClast, Cmax, tmax, Kel, t1/2, CL/F, and Vz/F in plasma Ae0-24, Fe%, and CLR in urine. Part 1 timepoints Day 1 (dose), 2, 8 and 15 (post-dose). 2. Pharmacodynamic (PD) response following SC doses of BC-006 in adults with obesity. Change from baseline of circulating biomarking proteins. Part 1 timepoints Day 1 (dose), Day 15, Day 29, Day 57 and Day 85 post-dose. 3. Pharmacokinetics (PK) of BC-006 metabolites following SC doses of BC-006 in adults with obesity. Pharmacokinetics (PK) parameters of BC-006 metabolites, including but not limited to: AUCinf, AUClast, Cmax, tmax, Kel, t1/2, CL/F, and Vz/F in plasma, Ae0-24, Fe%, and calculation of renal clearance (CLR) in urine. Part 1 timepoints Day 1 (dose), 2, 8 and 15 post-dose. | — |
Countries
New Zealand
Contacts
Public ContactYvonne Chen
Outcome results
None listed