HealthyPhase 1NCT02446340
Multiple Ascending Dose Safety Study of ShK-186 (Dalazatide) in Healthy Volunteers
A Phase 1 study testing dalazatide in people with Healthy, run by Kineta Inc. at 1 site in United States.
Trial summary
The purpose of this study is to examine safety outcomes in healthy volunteers after systemic administration of multiple ascending doses of dalazatide. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- dalazatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Apr 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy normal male and female subjects, ages 18 to 45, inclusive;
- able to communicate and able to provide valid, written informed consent;
- within the body mass index (BMI) range of approximately 18.0 to 30.0 kg/m2, inclusive;
- minimum weight of 50 kg;
- willingness to remain totally abstinent or use adequate contraception; e.g., 2 of the following methods: hormonal contraceptive, intrauterine device, condom, diaphragm, and spermicidal gel/foam) in order to prevent pregnancy from the screening visit until 60 days after the follow-up visit. For men, the donation of sperm during this period is also prohibited.
Who cannot join
- the presence of clinically significant medical history as determined by the investigator.
- the history of clinically significant cardiac abnormalities or presence of clinically significant abnormality on 12-lead ECG.
- the history of pre-existing paresthesia or neuropathy;
- abnormalities on neurologic exam at screening or baseline
- the history of any cancer requiring systemic chemotherapy or radiation; individuals with a history of non-melanoma skin cancer, nonrecurring carcinoma in situ treated with laser or cryotherapy or cervical cancer-in-situ, resected surgically with no evidence of disease, may be accepted on a case by case basis at the discretion of the Investigator;
- the presence of acute infection or history of acute infection within 7 days prior to receipt of the study drug; additionally, oral temperature may not exceed 37.4°C at baseline;
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- the presence of clinically significant laboratory abnormalities (chemistry panel of 20 analytes [Chem-20; fasted 10-12 hours], complete blood count [CBC], and urinalysis [UA]) as determined by the investigator;
- positive urine drug screen for drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, cotinine, tricyclic antidepressants and alcohol) at Screening or at Baseline.
- typical intake of more than 7 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
- a positive hepatitis screen (Hepatitis BsAg or anti-HCV) or positive Human Immunodeficiency Virus (HIV) antibody test ;
- a history of multiple drug allergies that are important in the view of the Investigator;
- any history of anaphylaxis or a history of allergy to a medication, diet, or environmental exposure (including bee stings) that are important in the view of the Investigator;
- participation in another clinical trial with receipt of an investigational product within 60 days of dose administration (or 5 half lives, whichever is longer);
- recent (within 1 year of Screening) history of illicit drug use;
- history of alcohol abuse that is important in the view of the Investigator
- inadequate venous access that would interfere with obtaining blood samples;
- use of prescription medications, over the counter products, herbal remedies and nutritional supplements within 7 days of study drug administration and throughout the study, or the anticipated need for prescription medications prior to Study Completion;
- recipients of blood transfusion or transfusion of blood or plasma products within 60 days of study drug administration;
- donation of blood > 500 mL within 2 months of study drug administration;
- positive pregnancy test at screening or at baseline (female subjects only);
- history within the past 3 months of eating disorders or other conditions which may lead to suspicion about the participant's nutritional status;
- inability or unwillingness to comply with study restrictions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ShK-186
The purpose of this study is to examine safety outcomes in healthy volunteers after systemic administration of multiple ascending doses of dalazatide.
Read the detailed description
The purpose of this study is to examine safety outcomes in healthy volunteers after systemic administration of multiple ascending doses of dalazatide delivered via subcutaneous injection twice per week for a total of 9 doses.
- Conditions
- Healthy
- Being tested
- dalazatide, placebo
- Keywords
- ShK-186, dalazatide, Kv1.3, SHK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalazatideDrug
Also called ShK-186
Different doses of drug, subcutaneous injection twice per week for a total of 9 doses.
placeboDrug
Also called Sub Q Placebo
Placebo delivered via subcutaneous administration twice per week for a total of 9 doses
| Study group | Role | What they receive |
|---|---|---|
| dalazatide 5ug | Experimental | 8 subjects, 6 given active agent and 2 given placebo Receives: Drug: dalazatide; Drug: placebo |
| dalazatide 15ug | Experimental | 8 subjects, 6 given active agent and 2 given placebo Receives: Drug: dalazatide; Drug: placebo |
| dalazatide 30ug | Experimental | 8 subjects, 6 given active agent and 2 given placebo Receives: Drug: dalazatide; Drug: placebo |
| dalazatide 60ug | Experimental | 8 subjects, 6 given active agent and 2 given placebo Receives: Drug: dalazatide; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects with adverse events
Measured: From randomization to Day 57 (14 time points)
Secondary outcomes (5)
Subjects with changes in vital signs
Vital signs include temperature, respiratory rate, supine blood pressure and pulse.
Measured: From randomization through Day 57 (14 time points)
Subjects with changes in symptom-directed physical examinations
Measured: From date of randomization to day 57 (14 timepoints)
Subjects with changes in 12-lead electrocardiograms
Measured: From date of randomization to day 57 (5 timepoints)
PK parameters
Parameters include Area under the plasma concentration versus time curve of dalazatide (AUC)
Measured: pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 4 hours post dose, 8 hours post dose, 12 hours post dose
Presence of specific anti-drug antibody
Serum evaluated for specific anti-drug antibody using ELISA-based immunoassay.
Measured: From date of randomization through Day 57 (4 timepoints).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kineta Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shawn Iadonato, PhD, Study chair, Kineta Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446340
- Sponsor's protocol ID
- 186-02
- Status last verified
- May 2015
- First submitted
- 15 Apr 2015
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ShK-186
- ClinicalTrials.gov ID
- NCT02446340
- Acronym / sponsor ID
- 186-02
- Conditions
- Healthy
- Keywords
- ShK-186, dalazatide, Kv1.3, SHK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kineta Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine safety outcomes in healthy volunteers after systemic administration of multiple ascending doses of dalazatide.
Detailed description
The purpose of this study is to examine safety outcomes in healthy volunteers after systemic administration of multiple ascending doses of dalazatide delivered via subcutaneous injection twice per week for a total of 9 doses.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| dalazatide 5ug | Experimental | Drug: dalazatide, Drug: placebo8 subjects, 6 given active agent and 2 given placebo |
| dalazatide 15ug | Experimental | Drug: dalazatide, Drug: placebo8 subjects, 6 given active agent and 2 given placebo |
| dalazatide 30ug | Experimental | Drug: dalazatide, Drug: placebo8 subjects, 6 given active agent and 2 given placebo |
| dalazatide 60ug | Experimental | Drug: dalazatide, Drug: placebo8 subjects, 6 given active agent and 2 given placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy normal male and female subjects, ages 18 to 45, inclusive;
- able to communicate and able to provide valid, written informed consent;
- within the body mass index (BMI) range of approximately 18.0 to 30.0 kg/m2, inclusive;
- minimum weight of 50 kg;
- willingness to remain totally abstinent or use adequate contraception; e.g., 2 of the following methods: hormonal contraceptive, intrauterine device, condom, diaphragm, and spermicidal gel/foam) in order to prevent pregnancy from the screening visit until 60 days after the follow-up visit. For men, the donation of sperm during this period is also prohibited.
Key exclusion criteria (22 listed)
- the presence of clinically significant medical history as determined by the investigator.
- the history of clinically significant cardiac abnormalities or presence of clinically significant abnormality on 12-lead ECG.
- the history of pre-existing paresthesia or neuropathy;
- abnormalities on neurologic exam at screening or baseline
- the history of any cancer requiring systemic chemotherapy or radiation; individuals with a history of non-melanoma skin cancer, nonrecurring carcinoma in situ treated with laser or cryotherapy or cervical cancer-in-situ, resected surgically with no evidence of disease, may be accepted on a case by case basis at the discretion of the Investigator;
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 |
|---|---|---|
| dalazatideAlso: ShK-186Different doses of drug, subcutaneous injection twice per week for a total of 9 doses. | Drug | dalazatide 15ug, dalazatide 30ug, dalazatide 5ug, dalazatide 60ug |
| placeboAlso: Sub Q PlaceboPlacebo delivered via subcutaneous administration twice per week for a total of 9 doses | Drug | dalazatide 15ug, dalazatide 30ug, dalazatide 5ug, dalazatide 60ug |
Primary outcome
Subjects with adverse events
Time frame: From randomization to Day 57 (14 time points)
5 secondary outcomes
Subjects with changes in vital signs
Time frame: From randomization through Day 57 (14 time points)
Subjects with changes in symptom-directed physical examinations
Time frame: From date of randomization to day 57 (14 timepoints)
Subjects with changes in 12-lead electrocardiograms
Time frame: From date of randomization to day 57 (5 timepoints)
PK parameters
Time frame: pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 4 hours post dose, 8 hours post dose, 12 hours post dose
Presence of specific anti-drug antibody
Time frame: From date of randomization through Day 57 (4 timepoints).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
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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.
Shawn Iadonato, PhD study chair
Kineta Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dalazatide in people with Healthy, run by Kineta Inc. at 1 site in United States.
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 5 inclusion and 22 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 18 May 2015. 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 States. 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?
Subjects with adverse events (time frame: From randomization to Day 57 (14 time points)). 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 18 May 2015.