LatrodectismPhase 1NCT04848714

Pharmacokinetic Study Protocol of ANAWIDOW Lyophilized Powder for Solution for Intravenous Use in Fasting Conditions

A Phase 1 study testing ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mL in people with Latrodectism, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

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 single-dose, open-label, single-treatment, single-period pharmacokinetic study under fasting conditions, in 12 healthy adult. To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL (dose: 3x10 mL vials) for… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Latrodectism
What is being tested?: ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mL
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteMexico
Study dates: 1 Jul 2021to 15 Feb 2022
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male and female subjects aged between 18 and 55 years (both inclusive).
Subject is a light or non- or ex-smoker (A light smoker 1 being defined as someone who is smoking ≤ 9 cigarettes per day and an ex-smoker being defined as someone who completely stopped smoking for at least 6 months before screening): If any subject stops smoking during last 6 months before day of 1 of the study and smoke ≤ 9 cigarettes per day, the subject will also be considered as a light-smoker.
With a weight ≥ 50.00 kg.
With a body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2.
Found healthy according to the clinical laboratory results and physical examination (performed within 21 days prior to the dosing of the study).
Have a normal 12-lead ECG and vital signs.

Show all 18Show fewer

Have laboratory test results within the laboratory's stated normal range, if not within this range, they must lack of clinical significance as judged by the PI or responsible physician.
If the subject of the study is female and childbearing potential / fertile (a woman is considered fertile after menstruation and until she becomes postmenopausal, unless she is permanently sterile), and agrees to use ONE of the following methods during the study: 21 days before of the dosage and up to at least 28 days after the last administration of the study medication. 9. Women not considered of childbearing / fertile if they meet ONE of the following points:
Postmenopausal for at least 1 year
Premenopausal woman with ONE of the following:
hysterectomy
bilateral salpingectomy
bilateral oophorectomy
The subject must be willing to use ONE of the following methods for 21 days before study drug dosing and at least 28 days after administration of the study medication;
Willing to remain abstinent.
Willing to use a male condom plus an additional contraceptive method.
Be able to communicate effectively and voluntarily agreed to participate in this study by signing written informed consent after being informed sufficiently about study aspects like objectives, study procedures, characteristics of the investigational drug, expected adverse events.
Subject willing to adhere to protocol requirements as evidenced by written informed consent approved by REC \& RC.

Who cannot join

Have any history of allergy or hypersensitivity to protein products of horse origin or IG or F(ab) or F(ab)2 or to any of its metabolites/derivatives or related drugs or excipients.
Or Study drug is contraindicated for medical reasons to the subject as per protocol section 3.7
Have a positive test result for hepatitis B surface antigen (HBs Ag), hepatitis C virus antibody (HCV Ab), HIV antibodies (types 1 and 2) and/or VDRL.
Have any history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, neurological or psychiatric disease or disorder (e.g., subjects with uncontrolled hypertension, phaeochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder and acute confusional states).
Presence of gastrointestinal, hepatic or kidney disease, or surgery or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
Have a history of alcohol abuse or drug abuse.

Show all 15Show fewer

Have a history of smoking ≥ 10 cigarettes per day during the last 6 months prior to screening.
History or presence of cancer.
Have any history of gastrointestinal ulcers / intestinal bleeding.
Have history of difficulty for donating blood.
Have clinically significant abnormal laboratory tests results.
Have a systolic blood pressure < 90 or > 140 mmHg or diastolic blood pressure is < 60 or > 90 mmHg.
Have a pulse rate less than 60 bpm or greater than 100 bpm (lower range will be accepted up to 45 bpm in case of athlete).
Have used any prescribed medication during the last 14 days preceding the first dosing, or use OTC, herbal products during the last 7 days or use medicinal enzyme inhibitors / inducers during las 30 days preceding the dosing.
Have participated in a drug research study or donated blood within the last 3 months.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico City, 11000

Other trials in Mexico

About this study

Official title: Pharmacokinetic Study of ANAWIDOW [Antivenin Latrodectus (Black Widow) Equine Immune F(ab´)2] Solution 10 mL for Intravenous Use of Laboratorios Silanes, S.A. de C.V. in Healthy Adult Male and Female Subjects Under Fasting Conditions.

Read the detailed description

To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL (dose: 3x10 mL vials) for intravenous use of Laboratorios Silanes, S.A. de C.V. in healthy adult human male and female subjects under fasting conditions. To assess the safety of single dose of ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL (dose: 3x10 mL vials) for intravenous use in healthy adult human male and female subjects under fasting conditions. In a minimum of 12 healthy adult. In this study, all subjects will be required to fast overnight for at least 10.00 hours prior to dosing at least 04.00 hours post-dose.

In this study, 3 ANAWIDOW 10 mL vials (3x10 mL) will be administered after diluting with normal saline solution up to 50 mL as intravenous infusion over 30 minutes. The solution will be infused through a 20-gauge catheter placed in the subject's left or right hand antecubital fossa at room temperature under fasting conditions.

Conditions: Latrodectism
Being tested: ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mL
Keywords: Latrodectus envenomation, Black Widow, Equine immune, F(ab´)2
Medical subject headings: Spider Bites

What participants receive

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

ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mLDrug
Also called ANAWIDOW
Antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mL for intravenous use [parenteral formulation]; hence, a single-dose fasting pharmacokinetic study is planned.

Study groups in NCT04848714
Study group	Role	What they receive
Group A: ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2]	Experimental	ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL Receives: Drug: ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mL

What is being measured

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

Maximum observed concentration following the treatment (Cmax).
To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL, employing the maximum observed concentration following the treatment (Cmax).
Measured: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
The area under the curve from time zero to the last measurable concentration (AUC 0-t)using the linear trapezoidal linear-interpolation method.
To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL, employing the area under the curve from time zero to the last measurable concentration (AUC 0-t) using the linear trapezoidal linear-interpolation method.
Measured: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
The area under the curve from time zero to infinity calculated (AUC 0-inf).
The area under the curve from time zero to infinity calculated (AUC 0-inf). Where AUC0-inf = AUC0-t + Ct/ λz, Ct is the last measurable concentration, and λz is the terminal elimination rate constant.
Measured: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
Time of the maximum measured concentration (Tmax).
To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL, employing the time of the maximum measured concentration (Tmax).
Measured: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
First order rate constant associated with the terminal portion of the curve (log-lineal), Lambda_z (Kel).
This is estimated via linear regression of time vs log concentration data. This parameter will be calculated using at least three or more non-zero serum concentration values.
Measured: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
The elimination half-life (HL_Lambda_z (t½))
The elimination half-life will be calculated as 0.693/ λz.
Measured: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
Vd (Volume of distribution)
A(t) (mg) / C(t) (mg/L) [A(t) represents the amount of drug in the body at time = t \& C(t) represents serum / plasma concentration of the drug at time = t]
Measured: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
Clearance (CL)
CL (body) = Kel x Vd (volume/hour)
Measured: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days

Secondary outcomes (7)

Physical examination
Physical examination will be performed before check-in of study period and may also be performed at any time during the study conduct if judged necessary by the physician.
Measured: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Sitting blood pressure (mmHg)
Vital signs will be measured and registered at the time of check-in, prior to dosing, at 01.00, 03.00 and 05.00 hours (within a range of ± 45 minutes) after the same and before the check-out.
Measured: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Pulse rate (p/m)
Vital signs will be measured and registered at the time of check-in, prior to dosing, at 01.00, 03.00 and 05.00 hours (within a range of ± 45 minutes) after the same and before the check-out.
Measured: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Respiratory rate (rr)
Vital signs will be measured and registered at the time of check-in, prior to dosing, at 01.00, 03.00 and 05.00 hours (within a range of ± 45 minutes) after the same and before the check-out.
Measured: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Axillary-body temperature (°C)
Vital signs will be measured and registered at the time of check-in, prior to dosing, at 01.00, 03.00 and 05.00 hours (within a range of ± 45 minutes) after the same and before the check-out.
Measured: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Hematology & biochemistry laboratory tests
Hematology \& biochemistry laboratory tests will be performed at the end of the study for all the subjects who administered with the study drug
Measured: 21 days
Medical examination
It will be performed before check -in, prior to the dosing and before the check-out.
Nevertheless, it may also be performed at any time during the study conduct if judged necessary by the physician.
Measured: Baseline, 2, 3, 4, 6, 10, 14 and 21 days

Timeline

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

1 Jul 202115 Feb 2022

First posted19 Apr 2021
Study start1 Jul 2021
Primary completion15 Aug 2021
Study completion15 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for LatrodectismStudies 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04848714
Sponsor's protocol ID: AS/BW/ENE-21/0003
Status last verified: Feb 2022
First submitted: 9 Apr 2021
Last updated: 2 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ryan NM, Buckley NA, Graudins A. Treatments for Latrodectism-A Systematic Review on Their Clinical Effectiveness. Toxins (Basel). 2017 Apr 21;9(4):148. doi: 10.3390/toxins9040148.
PubMed 28430165
Vazquez H, Chavez-Haro A, Garcia-Ubbelohde W, Mancilla-Nava R, Paniagua-Solis J, Alagon A, Sevcik C. Pharmacokinetics of a F(ab')2 scorpion antivenom in healthy human volunteers. Toxicon. 2005 Dec 1;46(7):797-805. doi: 10.1016/j.toxicon.2005.08.010. Epub 2005 Sep 28.
PubMed 16197974
Offerman SR, Daubert GP, Clark RF. The treatment of black widow spider envenomation with antivenin latrodectus mactans: a case series. Perm J. 2011 Summer;15(3):76-81. doi: 10.7812/TPP/10-136.
PubMed 22058673
Dart RC, Bush SP, Heard K, Arnold TC, Sutter M, Campagne D, Holstege CP, Seifert SA, Lo JCY, Quan D, Borron S, Meurer DA, Burnham RI, McNally J, Garcia-Ubbelohde W, Anderson VE. The Efficacy of Antivenin Latrodectus (Black Widow) Equine Immune F(ab')2 Versus Placebo in the Treatment of Latrodectism: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial. Ann Emerg Med. 2019 Sep;74(3):439-449. doi: 10.1016/j.annemergmed.2019.02.007. Epub 2019 Mar 27.
PubMed 30926190

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic Study of ANAWIDOW [Antivenin Latrodectus (Black Widow) Equine Immune F(ab´)2] Solution 10 mL for Intravenous Use of Laboratorios Silanes, S.A. de C.V. in Healthy Adult Male and Female Subjects Under Fasting Conditions.
ClinicalTrials.gov ID: NCT04848714
Acronym / sponsor ID: AS/BW/ENE-21/0003
Conditions: Latrodectism
Keywords: Latrodectus envenomation, Black Widow, Equine immune, F(ab´)2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
Collaborators: Rare Disease Therapeutics Inc.
Study start: 1 Jul 2021 (actual)
Primary completion: 15 Aug 2021 (actual)
Study completion: 15 Feb 2022 (actual)
First posted: 19 Apr 2021 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Group A: ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2]	Experimental	Drug: ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mLANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (18 listed)

Healthy adult male and female subjects aged between 18 and 55 years (both inclusive).
Subject is a light or non- or ex-smoker (A light smoker 1 being defined as someone who is smoking ≤ 9 cigarettes per day and an ex-smoker being defined as someone who completely stopped smoking for at least 6 months before screening): If any subject stops smoking during last 6 months before day of 1 of the study and smoke ≤ 9 cigarettes per day, the subject will also be considered as a light-smoker.
With a weight ≥ 50.00 kg.
With a body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2.
Found healthy according to the clinical laboratory results and physical examination (performed within 21 days prior to the dosing of the study).

Key exclusion criteria (15 listed)

Have any history of allergy or hypersensitivity to protein products of horse origin or IG or F(ab) or F(ab)2 or to any of its metabolites/derivatives or related drugs or excipients.
Or Study drug is contraindicated for medical reasons to the subject as per protocol section 3.7
Have a positive test result for hepatitis B surface antigen (HBs Ag), hepatitis C virus antibody (HCV Ab), HIV antibodies (types 1 and 2) and/or VDRL.
Have any history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, neurological or psychiatric disease or disorder (e.g., subjects with uncontrolled hypertension, phaeochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder and acute confusional states).
Presence of gastrointestinal, hepatic or kidney disease, or surgery or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.

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
ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mLAlso: ANAWIDOWAntivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mL for intravenous use [parenteral formulation]; hence, a single-dose fasting pharmacokinetic study is planned.	Drug	Group A: ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2]

Primary outcome

Maximum observed concentration following the treatment (Cmax).
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL, employing the maximum observed concentration following the treatment (Cmax).
The area under the curve from time zero to the last measurable concentration (AUC 0-t)using the linear trapezoidal linear-interpolation method.
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL, employing the area under the curve from time zero to the last measurable concentration (AUC 0-t) using the linear trapezoidal linear-interpolation method.
The area under the curve from time zero to infinity calculated (AUC 0-inf).
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
The area under the curve from time zero to infinity calculated (AUC 0-inf). Where AUC0-inf = AUC0-t + Ct/ λz, Ct is the last measurable concentration, and λz is the terminal elimination rate constant.
Time of the maximum measured concentration (Tmax).
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL, employing the time of the maximum measured concentration (Tmax).
First order rate constant associated with the terminal portion of the curve (log-lineal), Lambda_z (Kel).
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
This is estimated via linear regression of time vs log concentration data. This parameter will be calculated using at least three or more non-zero serum concentration values.
The elimination half-life (HL_Lambda_z (t½))
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
The elimination half-life will be calculated as 0.693/ λz.
Vd (Volume of distribution)
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
A(t) (mg) / C(t) (mg/L) [A(t) represents the amount of drug in the body at time = t \& C(t) represents serum / plasma concentration of the drug at time = t]
Clearance (CL)
Time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days
CL (body) = Kel x Vd (volume/hour)

7 secondary outcomes

Physical examination
Time frame: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Sitting blood pressure (mmHg)
Time frame: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Pulse rate (p/m)
Time frame: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Respiratory rate (rr)
Time frame: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Axillary-body temperature (°C)
Time frame: Baseline, 2, 3, 4, 6, 10, 14 and 21 days
Hematology & biochemistry laboratory tests
Time frame: 21 days
Medical examination
Time frame: Baseline, 2, 3, 4, 6, 10, 14 and 21 days

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 2 Mar 2022.
Background: PubMed 28430165Ryan NM, Buckley NA, Graudins A. Treatments for Latrodectism-A Systematic Review on Their Clinical Effectiveness. Toxins (Basel). 2017 Apr 21;9(4):148. doi: 10.3390/toxins9040148.
Background: PubMed 16197974Vazquez H, Chavez-Haro A, Garcia-Ubbelohde W, Mancilla-Nava R, Paniagua-Solis J, Alagon A, Sevcik C. Pharmacokinetics of a F(ab')2 scorpion antivenom in healthy human volunteers. Toxicon. 2005 Dec 1;46(7):797-805. doi: 10.1016/j.toxicon.2005.08.010. Epub 2005 Sep 28.
Background: PubMed 22058673Offerman SR, Daubert GP, Clark RF. The treatment of black widow spider envenomation with antivenin latrodectus mactans: a case series. Perm J. 2011 Summer;15(3):76-81. doi: 10.7812/TPP/10-136.
Background: PubMed 30926190Dart RC, Bush SP, Heard K, Arnold TC, Sutter M, Campagne D, Holstege CP, Seifert SA, Lo JCY, Quan D, Borron S, Meurer DA, Burnham RI, McNally J, Garcia-Ubbelohde W, Anderson VE. The Efficacy of Antivenin Latrodectus (Black Widow) Equine Immune F(ab')2 Versus Placebo in the Treatment of Latrodectism: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial. Ann Emerg Med. 2019 Sep;74(3):439-449. doi: 10.1016/j.annemergmed.2019.02.007. Epub 2019 Mar 27.
USFDA prescribing information ANAVIP® Crotalidae Immune F(ab')2 (Equine) Lyophilized Powder for Solution for Injection for Intravenous Use Only; Initial: 05/06/2015Link provided by the sponsor.
USFDA prescribing information ANASCORP® Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection Lyophilized for Solution for intravenous use only; Revised: July 2011Link provided by the sponsor.
Antivenin, black widow spider (Rx), Brand and Other Names: Antivenin (Latrodectus mactans), Medscape, Adverse EffectsLink provided by the sponsor.
A Phase III Multicenter Clinical Trial of Analatro® \[Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2\] in Patients with Systemic Latrodectism; Instituto Bioclon S.A. de C.VLink provided by the sponsor.
USFDA. Retention of Bioavailability and Bioequivalence Testing SamplesLink provided by the sponsor.
Individual participant dataSharing planned: No

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.

Federico A Arguelles Tello, M.D principal investigator

Avant Santé Research Center S.A. de C.V

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 inclusion and 15 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 2 Mar 2022. 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 Mexico. 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?

Maximum observed concentration following the treatment (Cmax). (time frame: Baseline, 00.08, 00.167, 00.25, 00.34, 00.50, 00.67, 00.83, 01.00, 01.50, 02.00, 04.00, 06.00, 12.00, 24.00,and 2, 3, 4, 6, 10, 14 and 21 days). The study lists 8 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 NCT04848714, which also lists 4 linked publications.

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 2 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.