A trial comparing ACP-011 administered as a single dose via a syringe and needle versus an auto-injector
A Single Center, Phase 1, Randomized, Open-Label Bioequivalence Trial in Healthy Volunteers Comparing ACP-011 Administered as a Single Dose via Syringe and Needle vs. Auto-Injector
Ascendis Pharma Endocrinology Division A/S
26 participants
Nov 13, 2017
Interventional
Conditions
Summary
This study aims to investigate an alternative method of administration, an auto-injector device containing ACP-011 compared to the usual needle and syringe. This research project is testing and comparing the safety, tolerability, pharmacokinetics (the amount of study drug and it’s breakdown products in your blood), pharmacodynamics (how your body is affected by the study drug) and immunogenicity (how your immune system is affected by the study drug) of ACP-011. Approximately 26 healthy male participants will be enrolled across 2 cohorts (groups). Each cohort will consist of 13 participants. The study medication will be administered through two methods over two periods, Particpants will receive both treatment methods in a particular sequence. The dose of study drug will be the same for each method. Participants will not have a choice as to which method or treatment sequence assigned, this will random (like flipping a coin). After the first treatment period, there will be a 14 day period where there will not be any study medication given. This period is known as a wash-out period. Treatment A: consists of a single subcutaneous (SC) (just under the skin) injection to the abdomen administered via syringe and needle. Treatment B: consists of a single SC injection administered via the auto-injector to the same quadrant of the abdomen as the previous injection (depending on sequence). Total participation in the study consists of 45 days which is broken up into 3 phases: - Screening Phase: During which participants will undergo suitability assessments - Treatment Phase: During which participants will be required to stay overnight in the unit for 8 consecutive nights on two separate occasions. Following this participants will be required to attend the study centre on 3 separate occasions - Washout Phase: in between the inpatient stays, where no study visits are required.
Eligibility
Inclusion Criteria6
- Healthy Male Adults aged between 18 and 65 years at time of informed consent
- Body weight between 60.50 and 73.90 kg
- Body mass index (BMI) between19 and 29 kg/m2
- Considered to be in good general health at screening as determined by investigator
- Able to comply with all protocol requirements.
- Able to provide written informed consent.
Exclusion Criteria22
- History of clinically significant (in the opinion of the investigator) endocrine disease; history or presence of endocrine tumors, thyroid disease, diabetes, or impaired glucose tolerance.
- History of malignancy of any organ system (other than localized basal or squamous cell carcinomas of the skin), treated or untreated within the past 5 years.
- Clinically significant (in the opinion of the investigator) history of neurological, cardiovascular, respiratory, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease, glaucoma, a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
- On a 12-lead ECG, the subject has any of the following at screening, confirmed by repeat assessment:
- PR greater than or equal to 221 ms
- QRS greater than or equal to 120 ms
- QTcF greater than or equal to 451 ms
- Systolic blood pressure <90 mmHg and >140 mmHg; diastolic blood pressure <40 mmHg and > 90 mmHg
- Known or suspected HIV-positive status
- Known or suspected infection with hepatitis B or C
- Use of any prescription or over-the-counter medications (including herbal or nutritional supplements) within 14 days before the first dose of study drug.
- Consumption of alcohol-containing products within 48 hours before dosing with study drug.
- Social smokers who are otherwise healthy may be enrolled if they have not used nicotine containing products within 2 weeks prior to dosing.
- History of alcohol or drug abuse
- Strenuous activity or contact sports within 24 hours before dosing with study drug or during the study.
- Donation of blood or blood products >450 mL within 30 days before dosing with study drug.
- Presence of contraindications to hGH treatment
- Known hypersensitivity to the components of the trial medication
- Any medical abnormality unless approved by Medical Monitor
- History of relevant drug and/or allergies (ie, allergy to ACP-011, or excipients, or any significant food allergy that would preclude a standard diet in the clinic).
- Participation in drug trial in which receipt of a study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to study entry
- Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
This is a single center, phase 1, randomized, open-label, single dose, crossover study in healthy adult subjects designed to compare the PK and PD of two injection modalities of ACP-011 to confirm bioequivalence (BE). PK (hGH) will be evaluated by Cmax and AUC, and the PD (IGF-1) will be evaluated by Emax and AUEC. ACP-011 will be administered at a fixed nominal dose of 13.3 mg hGH corresponding to 0.20 mg hGH/kg subcutaneously (SC) to healthy subjects via syringe and needle versus the auto-injector during two separate periods separated by interval washout period. The screening period will occur between Days –28 and –2; subjects will be admitted to the clinic site on Day –1. Two treatments modalities will be available, ACP-011 administered by syringe and needle (termed ‘A’) ACP-011 administered by auto-injector (termed ‘B’). Approximately 26 healthy male subjects will be randomly assigned to receive one of the two treatment modality sequences, AB or BA. A (or B, depending on sequence) will be given during Period 1, followed by B (or A, depending on sequence) in Period 2 with an interval of at least 14 days in between. Treatment modality A consists of a single subcutaneous injection of ACP-011 13.3 mg hGH administered via syringe and needle to the abdomen. Treatment modality B consists of a single SC injection of ACP-011 13.3 mg hGH administered via the auto-injector. Both injections will be administered to the same quadrant of the abdomen. On the morning of Day 1 of Period 1, subjects will receive a single dose of ACP-011 according to the assigned administration method. On the morning of Day 1 of Period 2, subjects will cross over to receive a single dose of ACP-011 via the alternate administration method. Each dose will be followed by 15 days of PK and PD sampling. Subjects will be admitted on Day –1 and remain in the clinic until the morning of Day 8. They will return for outpatient visits on Days 9, 11, and 15 in each treatment period for safety, PK, and PD assessments. Discharge from the study will occur after all assessments are completed on Day 15 (cumulative Day 44) of Period 2.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12617001471370