A Phase I Randomised, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamicsand Effect of Food on the Bioavailability of SKY-0515 in Healthy Volunteers

Phase 1

Recruiting

• Conditions: Huntington's Disease; Neurological - Neurodegenerative diseases; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

• Registration Number: ACTRN12623001161617
• Lead Sponsor: Skyhawk Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-09
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Volunteers will be included in Part A and B of the study only if they satisfy all the following criteria:
1. Must have given written informed consent, before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2. Healthy male or female, aged between 18 and 70 years, inclusive at screening.
3. Body mass index (BMI) of 18 to 35 kg/m2, inclusive, with body weight greater than or equal to 50.0 kg and < 130.0 kg.
4. Participant is medically healthy (in the opinion of the Investigator), as determined by pre-study medical history and without CS abnormalities
5. Female participants must be of non-child-bearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or, if of child-bearing potential:
a. Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on Day -1.
b. Must agree not to donate ova or attempt to become pregnant from the time of signing consent until at least 30 days after the last dose of study drug.
c. If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception) from one month prior to screening until at least 30 days after the last dose of study drug. Participants who choose true abstinence during study participation will be considered for study participation even if this is not in line with their typical lifestyle.
6. Male participants must:
a. Agree not to donate sperm from the time of signing consent until at least 180 days after the last dose of study drug.
b. If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception (defined as use of a condom plus a highly effective method of contraception for their partner from the time of signing consent until at least 180 days after the last dose of study drug).
7. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and
other study procedures.

Exclusion Criteria

Volunteers will be excluded from Part A and B of the study if there is evidence of any of the
following:
1. Any active infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
2. Suffers from frequent or recurrent infections (defined as greater than or equal to 3 recurrent or separate occurrences in the 12 months preceding first study drug administration or 2 recurrent or separate occurrences in the 6 months preceding first study drug administration).
3. Active malignancy and/or any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma or low grade cervical intraepithelial neoplasia).
4. Evidence of clinically relevant immunosuppression, including (but not limited to), immunodeficiency conditions such as common variable hypogammaglobulinemia.
5. History of hypersensitivity reaction, anaphylaxis or other CS reactions or known allergy to the study drug or its ingredients.
6. Presence or history of cardiovascular disease (including unstable angina, myocardial infarction, chronic heart failure).
7. History of any CS disorder, including haematologic, pulmonary, hepatic, renal, GI, connective tissue disease, uncontrolled endocrine/metabolic, neurologic (including seizures, strokes, brain tumours), and psychiatric diseases, or any disorder that may prevent the successful completion of the study or influence the absorption, distribution, metabolism, excretion, or action of the study drug.
8. Presence or having sequelae of GI, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
9. History of surgery or hospitalisation within 12 weeks prior to screening, or surgery planned during the study.
10. Lack of suitable veins for multiple venepunctures/cannulations as assessed by the Investigator or delegate at screening or Day -1.
11. Participant has significant (> 10%) weight gain or loss between screening and Day -1.
12. Participant has donated blood/blood products or experienced significant blood loss within 3 months prior to the first dose administration.
13. Any clinically relevant laboratory finding or medical condition that could place the subject at risk for participation in the study, in the opinion of the Investigator.
14. Regular consumption of >10 standard alcoholic drinks/week where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc/Vol], 100 mL wine [12% Alc/Vol], 30 mL spirit [40% Alc/Vol]), and/or participant is unwilling to abstain from alcohol while confined to the study clinic.
15. Participant is unwilling to abstain from smoking for at least 48 hours prior to check-in (Day -1) and while confined to the study clinic.
16. Participant is breastfeeding/lactating or pregnant, or planning to breastfeed or become pregnant during the study.
17. Known substance abuse or medical, psychological, or social conditions that, in the opinion of the PI (or delegate), may interfere with the participants inclusion in the clinical study or evaluation of the clinical study results.
18. Any other condition or prior therapy that in the opinion of the Investigator (or delegate) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified