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HealthyPhase 1NCT03847207

A Study in Healthy Subjects to Assess the Safety, Tolerability, PK and PD of HTL0030310

A Phase 1 study testing HTL0030310 and Pasireotide in people with Healthy, run by Nxera Pharma UK Limited at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase 1, first in human, three-part, single centre study to assess the safety, tolerability, PK and PD of single ascending subcutaneous doses of HTL0030310 in healthy subjects Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
HTL0030310 and Pasireotide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteUnited Kingdom
Study dates
23 Jan 2019to 5 Mar 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males or healthy a woman is considered of childbearing potentiaL (WONCBP); a WONCBP unless she is permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone [FSH] concentration ≥40 IU/L).
  • Age 18 to 50 years of age
  • A BMI of 20.0 to 30.0 kg/m2, with a minimum weight of 45 kg
  • Must be willing and able to communicate and participate in the whole study
  • Must provide written informed consent
  • Must agree to adhere to the contraception requirements defined in the protocol (Section 9.4)

Who cannot join

  • Subjects who have received any IMP in a clinical research study within the previous 3 months of screening
  • Subjects who are study site employees, or immediate family members of a study site or sponsor employee
  • Subjects who have previously been enrolled in this study. Subjects who have taken part in Part 1/Part 2 are not permitted to take part in Part 2/Part 3
  • History of any drug or alcohol abuse in the past 2 years
  • Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
  • Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and admission
Show all 26Show fewer
  • Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
  • Females of childbearing potential. A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum FSH concentration ≥40 IU/L). All female subjects must have a negative urine pregnancy test
  • Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
  • Subjects with vital signs outside the normal range for healthy volunteers (HR < 50 or >90 bpm; Systolic BP > 140 mmHg; Diastolic BP > 90 mmHg)
  • Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1 of the protocol)
  • Fasting blood glucose at screening above the upper limit of normal (3.9 to 5.8 mM)
  • HbA1c at screening above the upper limit of normal (>6%)
  • Abnormal renal function - defined as creatinine clearance < 70mL/min using the Cockcroft-Gault equation at screening
  • Abnormal hepatic function - defined as ALT, AST and total bilirubin > 1.5 x upper limit of normal at screening
  • Positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1 of the protocol)
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
  • History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator
  • Family history of long QT syndrome or sudden cardiac death in a young adult where a cause of arrhythmia cannot be excluded
  • QTcF at screening >450 msec in males or >470 msec in females
  • Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients, including glucose/fructose intolerance for the standard OGTT
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
  • Donation or loss of greater than 400 mL of blood within the previous 3 months
  • Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than up to 4 g per day paracetamol) or herbal remedies (including St. John's Wort) in the 21 days before IMP administration (See Section 11.4 of protocol). Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor
  • Subjects with tattoos or scars on the abdomen which may interfere with injection site assessments or pharmacodynamic measurements, as determined by the PI or delegate at screening
  • Failure to satisfy the investigator of fitness to participate for any other reason Exclusion criteria 11, 16, 22, 24 and 26 from the list above will be re-assessed at admission/pre-dose.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Quotient Sciences

    Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Three-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of HTL0030310 in Healthy Subjects

A Phase 1, first in human, three-part, single centre study to assess the safety, tolerability, PK and PD of single ascending subcutaneous doses of HTL0030310 in healthy subjects

Read the detailed description

This is a first in human, three part study with the objective to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of HTL0030310 in healthy subjects. Part 1 is a double-blind, placebo-controlled, randomised study assessing single ascending doses of HTL0030310. Part 2 is a site-blind (sponsor unblinded), placebo-controlled, part-randomised, fixed-sequence, single-dose, 4-period study assessing the PD of a positive control, pasireotide, following administration of challenge agents. Part 3 is a double-blind, placebo-controlled, part-randomised, fixed-sequence, single-dose, HTL0030310 proof of pharmacological effect study, where PD effects of HTL0030310 will be investigated following administration of challenge agents. The challenge agents administered in this study will be: oral glucose tolerance test (OGTT), Growth hormone-releasing hormone (GHRH), and corticotrophin releasing hormone (CRH) combined with desmopressin.

Conditions
Healthy
Being tested
HTL0030310, Pasireotide, Placebo
Keywords
First in Human, Single Ascending Dose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HTL0030310Drug

    Solution for Subcutaneous injection

  • PasireotideDrug

    Pasireotide 600 μg for subcutaneous injection

  • PlaceboDrug

    Matching placebo Solution

Study groups in NCT03847207
Study groupRoleWhat they receive
Part 1 Single Ascending DoseExperimentalEight subjects in up to 8 cohorts will be dosed. A single subcutaneous injection of HTL0030310 or placebo will be administered. In each cohort, 6 subjects will receive HTL0030310 and 2 subjects will receive placebo.
Receives: Drug: HTL0030310; Drug: Placebo
Part 2 Pasireotide PD AssessmentExperimentalSixteen subjects in 2 cohorts (8 subjects per cohort) will be dosed on 4 occasions. Within each cohort, 4 subjects will be randomised to active dosing with CRH with desmopressin, GHRH and OGTT challenge and 4 subjects will be randomised to placebo dosing with CRH with desmopressin, GHRH and OGTT challenge.
Receives: Drug: Pasireotide; Drug: Placebo
Part 3 Proof of Pharmacological EffectExperimentalUp to 80 subjects in 4 cohorts (up to 20 subjects per cohort) will be dosed in up to 3 study periods. In each period, subjects will receive active drug or placebo with GHRH, OGTT and CRH with desmopressin (optional).
Receives: Drug: HTL0030310; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of treatment related adverse events (as determined by abnormal clinical laboratory tests, vitals signs, ECG parameters, Holter ECG parameters and injection site reactions)

    Safety and Tolerability

    Measured: Admission up to 8 days post dose

  2. Part 2 and Part 3 Area under the effect time curve (EAUC) 1) for insulin, glucose, glucagon, GLP1, C-peptide and GIP level 2) for GH 3) ACTH and cortisol

    Pharmacodynamics

    Measured: Predose up to 4 hours post dose

  3. Part 2 and Part 3 Maximum observed effect (EMax) 1) for insulin, glucose, glucagon, GLP1, C-peptide and GIP level 2) for GH 3) ACTH and cortisol

    Pharmacodynamics

    Measured: Predose up to 4 hours post dose

  4. Part 2 and Part 3 Time to reach Maximum observed effect (TEMax) 1) for insulin, glucose, glucagon, GLP1, C-peptide and GIP level 2) for GH 3) ACTH and cortisol

    Pharmacodynamics

    Measured: Predose up to 4 hours post dose

Secondary outcomes (10)

  1. Part 1 Maximum observed plasma concentration (Cmax) of single subcutaneous doses of HTL0030310

    Pharmacokinetics

    Measured: Pre dose to 144 hours post dose

  2. Part 1 Time to reach Maximum observed plasma concentration (Tmax) of single subcutaneous doses of HTL0030310

    Pharmacokinetics

    Measured: Pre dose to 144 hours post dose

  3. Part 1 Area under the curve (AUC) of single subcutaneous doses of HTL0030310

    Pharmacokinetics

    Measured: Pre dose to 144 hours post dose

  4. Part 2 Maximum observed plasma concentration (Cmax) of single subcutaneous doses of pasireotide

    Pharmacokinetics

    Measured: Predose to 24 hours postdose

  5. Part 2 Time to reach Maximum observed plasma concentration (Tmax) of single subcutaneous doses of pasireotide

    Pharmacokinetics

    Measured: Predose to 24 hours postdose

  6. Part 2 Area under the curve (AUC) of single subcutaneous doses of pasireotide

    Pharmacokinetics

    Measured: Predose to 24 hours postdose

  7. Part 3: Number of treatment related adverse events (as determined by abnormal clinical laboratory tests, vitals signs, ECG parameters and injection site reactions)

    Safety and Tolerability

    Measured: Admission up to 8 to 10 days post final dose

  8. Part 3 Maximum observed plasma concentration (Cmax) of single subcutaneous doses of HTL0030310

    Pharmacokinetics

    Measured: Predose to 96 hours postdose

  9. Part 3 Time to reach Maximum observed plasma concentration (Tmax) of single subcutaneous doses of HTL0030310

    Pharmacokinetics

    Measured: Predose to 96 hours postdose

  10. Part 3 Area under the curve (AUC) of single subcutaneous doses of HTL0030310

    Pharmacokinetics

    Measured: Predose to 96 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2019
  2. Study start23 Jan 2019
  3. Primary completion5 Mar 2020
  4. Study completion5 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03847207
Sponsor's protocol ID
HTL0030310-101
Other IDs
2018-003169-33, QSC200729, 2018
Status last verified
Feb 2025
First submitted
18 Jan 2019
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HTL0030310 and Pasireotide in people with Healthy, run by Nxera Pharma UK Limited at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of treatment related adverse events (as determined by abnormal clinical laboratory tests, vitals signs, ECG parameters, Holter ECG parameters and injection site reactions) (time frame: Admission up to 8 days post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03847207.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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