None - Study is to Determine Safety in Healthy ParticipantsEarly Phase 1NCT03772678
A Phase I Study to Evaluate LSALT Peptide
A Early Phase 1 study testing LSALT peptide and 0.9% Saline in people with None - Study is to Determine Safety in Healthy Participants, run by Arch Biopartners Inc. at 1 site in Australia.
Trial summary
A phase I double-blind, placebo-controlled, randomized, single and multiple ascending dose finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- None - Study is to Determine Safety in Healthy Participants
- What is being tested?
- LSALT peptide and 0.9% Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Jun 2019to 31 Mar 2020
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No prior history of major organ or systemic disease including diabetes, hypertension, kidney, heart or liver disease. Participants with childhood asthma are acceptable.
- Normal hematology, clinical chemistry and urinalysis parameters at screening, unless not deemed clinically significant by the investigator.
- Body Mass Index (BMI) between 18 kg/m2 and 32 kg/m2 (inclusive)
- Taking no prescription medications 2 weeks prior to admission or over-the-counter medications 7 days prior to admission. Occasional use of paracetamol or ibuprofen (up to 1000 mg and 400 mg/day respectively) are acceptable. Routine vitamins and supplements are permissible at the discretion of the investigator.
- Able to allow intravenous medication to be administered.
- Males (along with their female partners) and females of childbearing potential (defined as a female who is not menopausal or surgically sterilized) must be willing to use an acceptable method of birth control during heterosexual activities including a condom and a second highly effective method (i.e., hormonal contraceptive, intra-uterine device) or abstinence for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Males should continue with the aforementioned contraception for 90 days after the last dose and females should continue with the aforementioned contraception for 60 days after last dose.
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- Able to understand and willing to sign an ethics committee-approved written informed consent document
- Non-smokers. Social and light smokers of up to 10 cigarettes per day who can abstain from smoking during the confinement period and have no evidence of underlying lung disease (bronchitis, COPD or reactive airways disease).
- Willing to remain abstinent from alcohol 24 hours prior to admission and until after the confinement period in the unit.
Who cannot join
- A history of cardiovascular disease, diabetes or hypertension (>150/90 after 5 minutes sitting), significant neurological, pulmonary (including asthma), hepatic, rheumatic, autoimmune, haematological, metabolic or renal disorder.
- Prescription medications are prohibited. No prescription medications 2 weeks prior to admission or over-the-counter medications 7 days prior to admission. Occasional use of paracetamol or ibuprofen (up to 1000 mg and 400 mg/day respectively) are acceptable. Routine vitamins and supplements are permissible at the discretion of the investigator.
- Any moderate or severe allergies, including anaphylaxis, to food, drugs or environmental allergens. Mild allergies such as hayfever may be included.
- Females who are pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study initiation and at baseline.
- Consumption of caffeine 48 hours prior to start of study treatment and whilst confined to the unit.
- History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study
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- Clinically significant abnormal laboratory value at screening as determined by the Investigator.
- Participant is sero-positive to HIV-1 or HIV-2, HCV or HBV.
- History or presence of alcoholism within two years prior to the first study drug administration or drugs of abuse unless it can be explained to the satisfaction of the investigator that it is due to a standard dose of a prescribed medication and that an adequate wash-out will occur prior to admission.
- No findings on clinical examination that, in the opinion of the investigator, could compromise the safety of the participant or the results of the study.
- Blood donation or significant blood loss within 60 days prior to the first study drug administration.
- Administration of investigational product in another trial within 30 days prior to the first study drug administration or five half-lives, whichever is longer.
- Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant.
- Active malignancy or history of malignancy in the past 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Finding Study to Evaluate the Safety and Pharmacokinetic Profile of LSALT Peptide in Healthy Participants
A phase I double-blind, placebo-controlled, randomized, single and multiple ascending dose finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in healthy participants
- Being tested
- LSALT peptide, 0.9% Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSALT peptideDrug
novel 16 amino acid peptide
0.9% SalineOther
saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0.9% Saline For SAD and MAD arms. Receives: Other: 0.9% Saline |
| Single Ascending Dose - Low Dose | Experimental | LSALT peptide (1mg/mL in 0.9% saline) Single escalating dose - 0.01mg, 0.1mg, 0.3mg, 0.5mg intravenously Escalation to 2.5mg and 5mg doses in next cohorts if no adverse effects are seen after 10-14 days. Receives: Drug: LSALT peptide |
| Single Ascending Dose | Experimental | LSALT peptide (1mg/mL in 0.9% saline) Single dose - 1mg intravenously over 2h Escalation to next dose in next participant every 72h if no adverse effects are seen. Receives: Drug: LSALT peptide |
| Multiple Ascending Dose | Experimental | LSALT peptide (1mg/mL in 0.9% saline) Dose will be determined based on results of SAD arm. LSALT will be administered intravenously once or twice daily for 3 days. Receives: Drug: LSALT peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation
To determine the safety and tolerability of 3 single and multiple ascending doses of LSALT peptide (1.0mg, 2.5mg, 5.0mg) in healthy participants.
Measured: Within 21 days
Secondary outcomes (1)
Pharmacokinetic Evaluation
To evaluate the PK and pharmacodynamics (PD) of LSALT peptide in healthy participants.
Measured: Within 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start27 Jun 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for None - Study is to Determine Safety in Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arch Biopartners Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772678
- Sponsor's protocol ID
- AB001
- Status last verified
- Nov 2024
- First submitted
- 9 Dec 2018
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Finding Study to Evaluate the Safety and Pharmacokinetic Profile of LSALT Peptide in Healthy Participants
- ClinicalTrials.gov ID
- NCT03772678
- Acronym / sponsor ID
- AB001
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Arch Biopartners Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase I double-blind, placebo-controlled, randomized, single and multiple ascending dose finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in healthy participants
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: 0.9% Saline0.9% Saline For SAD and MAD arms. |
| Single Ascending Dose - Low Dose | Experimental | Drug: LSALT peptideLSALT peptide (1mg/mL in 0.9% saline) Single escalating dose - 0.01mg, 0.1mg, 0.3mg, 0.5mg intravenously Escalation to 2.5mg and 5mg doses in next cohorts if no adverse effects are seen after 10-14 days. |
| Single Ascending Dose | Experimental | Drug: LSALT peptideLSALT peptide (1mg/mL in 0.9% saline) Single dose - 1mg intravenously over 2h Escalation to next dose in next participant every 72h if no adverse effects are seen. |
| Multiple Ascending Dose | Experimental | Drug: LSALT peptideLSALT peptide (1mg/mL in 0.9% saline) Dose will be determined based on results of SAD arm. LSALT will be administered intravenously once or twice daily for 3 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- No prior history of major organ or systemic disease including diabetes, hypertension, kidney, heart or liver disease. Participants with childhood asthma are acceptable.
- Normal hematology, clinical chemistry and urinalysis parameters at screening, unless not deemed clinically significant by the investigator.
- Body Mass Index (BMI) between 18 kg/m2 and 32 kg/m2 (inclusive)
- Taking no prescription medications 2 weeks prior to admission or over-the-counter medications 7 days prior to admission. Occasional use of paracetamol or ibuprofen (up to 1000 mg and 400 mg/day respectively) are acceptable. Routine vitamins and supplements are permissible at the discretion of the investigator.
- Able to allow intravenous medication to be administered.
Key exclusion criteria (14 listed)
- A history of cardiovascular disease, diabetes or hypertension (>150/90 after 5 minutes sitting), significant neurological, pulmonary (including asthma), hepatic, rheumatic, autoimmune, haematological, metabolic or renal disorder.
- Prescription medications are prohibited. No prescription medications 2 weeks prior to admission or over-the-counter medications 7 days prior to admission. Occasional use of paracetamol or ibuprofen (up to 1000 mg and 400 mg/day respectively) are acceptable. Routine vitamins and supplements are permissible at the discretion of the investigator.
- Any moderate or severe allergies, including anaphylaxis, to food, drugs or environmental allergens. Mild allergies such as hayfever may be included.
- Females who are pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study initiation and at baseline.
- Consumption of caffeine 48 hours prior to start of study treatment and whilst confined to the unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSALT peptidenovel 16 amino acid peptide | Drug | Multiple Ascending Dose, Single Ascending Dose, Single Ascending Dose - Low Dose |
| 0.9% Salinesaline | Other | Placebo |
Primary outcome
Safety Evaluation
Time frame: Within 21 days
To determine the safety and tolerability of 3 single and multiple ascending doses of LSALT peptide (1.0mg, 2.5mg, 5.0mg) in healthy participants.
1 secondary outcome
Pharmacokinetic Evaluation
Time frame: Within 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LSALT peptide and 0.9% Saline in people with None - Study is to Determine Safety in Healthy Participants, run by Arch Biopartners Inc. at 1 site in Australia.
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 9 inclusion and 14 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 29 Nov 2024. 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety Evaluation (time frame: Within 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2024.